Links to 976 Entry-Level Biotechnology & Life Science Jobs

May perform USP and EP monograph testing activities using wet chemical and analytical instrumentation. Can conduct routine testing per NAMSA SOPs for as well feasibility, one-off protocol driven methodology, and/or method verifications on at least one of the following instrument types: HPLC, GC, or ICP. Conduct the study according to written instructions. Prepare and maintain the reagents required for testing.

The Field Service Engineer performs field installations, service, and preventative maintenance on the NanoString instrument portfolio. Install instrumentation in both research and medical diagnostic laboratories in accordance with IQ/OQ/PQ procedures. Perform annual preventative maintenance procedures on systems installed at customer sites. Document all activities and update/maintain instrument configuration databases in compliance with all Quality Assurance procedures

The candidate will play a key role in the organization by being responsible for the planning and timely execution of in vitro biochemical and cell-based assays for Nanosyn’s screening and profiling services.  He/She will be responsible for consistently generating high quality data and meeting agreed upon timelines.  Applicants must have a strong focus on quality and attention to detail, have the ability to work on multiple projects simultaneously, and be productive both independently and as part of a team.

The Lab Assistant is responsible for providing support throughout the facility by collecting, washing, sterilizing, and stocking laboratory glassware and consumable supplies. Also, be responsible for supporting the laboratory operations of the organization i.e., in shipping and receiving, ordering/installing of Liquid nitrogen tank.  Lab assistant also has the possibility to provide assistant bench prep work based on the research demands of the department. All bench prep work is S.O.P. based and held to a high standard. As a team member of the Process Development Group you will work to support process development activities.

The Associate QC Operation Trainer supports the operation training team through various tasks and responsibilities, while becoming proficient in various laboratory assays. Maintains an active list of every lab personnel’s current department and training logs ensuring all employees are properly and consistently trained and competent. Initiates initial training of new processes, document revisions, and products. Initiates the Read and Understood workflow of our quality documents through Veeva Vault, Confluence and our Learning Management System (LMS), and any other learning management system. Assists in providing training documentations/records as needed during audits. etc.

The Clinical Trial Assistant (CTA) will assist with the coordination of research studies, including maintaining Trial Master Files, tracking specimen procurement, tracking participant data and other study duties and organization. Maintain project and study-related documents including informed consent forms, clinical trial outlines, monitoring plans, synopses, IRB study protocols, and amendments, and clinical summaries, as required Follow protocol and assist with & coordinate training of study personnel on protocol and study manuals with external research sites

This position accessions patient samples according to standard operating procedures (SOP) with high efficiency and accuracy. Create new orders on Laboratory Inventory Management System (LIMS) and perform necessary checks to ensure proper accessioning. Accession samples with high accuracy and efficiency. Accurately enter patient data into the Laboratory Inventory Management System (LIMS). Scan test requisition forms and attached paperwork. Ensure that all paperwork belong to patient and upload to case.

This position will work closely with other team members and be responsible for personal and plant safety, environmental compliance, commitment to continuous improvement in the quality of our product, cost control efforts and efficient operations of the plant

The Quality Technician is a critical team member to handle Device History Records (DHR) Release, calibration activities, and inspection of sterile products. Ensure Device History Records (DHR) comply with requirements per the current Good Manufacturing Practices (GMP’s), which includes filing and retrieving DHR’s. Responsible for oversight of the calibration and preventive maintenance program, including, scheduling outside calibration house activities, coordinating with internal subject matter experts and monitoring calibration certificates. Implement, coordinate and assist with other projects as assigned including team participation.

In this part-time position you will work on-site at one or more hospital locations and be trained to screen newborns for common medical disorders that may occur in or after the newborn phase.  In addition to performing the newborn screening tests, you will also work alongside and interact with nurses, doctors and other members of the Birth Center team at the hospital to ensure that each family has a wonderful experience during this special time in their lives.

The Laboratory Analyst conducts testing in accordance with established procedures using Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and under the supervision of the Study Director. Additionally, Laboratory Analysts record data concurrently, maintain traceability of samples throughout testing and notify the Study Director of any unforeseen circumstances that occur during testing.

Performs laboratory tests and services to support customer data generation through sample processing and DNA extraction. Uses a variety of scientific techniques, instrumentation, and disciplines by performing the following duties: Performs sample and reagent preparation, DNA extraction and isolation, quality analysis prior to genotyping, analysis of reagents for performance, and other related tasks. Assist in the training of new assistants and interns in order to better manage laboratory workload. Proficiency in providing input to the best ways to maximize laboratory efficiency. etc

The QC lab technician position requires the candidate to prepare microbiological media and buffers. Other responsibilities include; prepping and cleaning the laboratory for daily use, perform preventative maintenance on equipment, maintain and organize QC retains and meeting goals set by the department. The ideal candidate would have some laboratory experience.

The ideal candidate will possess a knowledge of instrumentation such as FTIR, HPLC, UV/VIS, and KF to be used in the routine analytical testing of samples supporting incoming raw materials, in-process production, finished product, and validation. The selected candidate will be responsible for performing instrument/method troubleshooting as well as validation, qualification, calibration, and preventative maintenance, and performing investigations on out-of-specification and out-of-trend results. The selected candidate will participate in QA functions of the QCU including document review, room and equipment log review, room cleaning approvals, and other quality functions as assigned by the Director of AS Quality Systems.

Performs laboratory tests and services to support customer data generation within the platform specific processing lab, through a variety of scientific techniques, instrumentation, and disciplines by performing the following duties: Preforms all duties essential to quality high throughput data generations associated with platform specific technology-including but not limited to assigned primary platform and/or secondary platform(s). Gain and maintain the ability to operate all electronic and robotic equipment essential to primary platform processing. This includes all hand held electronic repeaters, multichannel pipettes along with liquid handling robots. Maintain consistency and quality in lab techniques and procedures within an ever changing and fluid work environment.

Perform microbiology department related tests according to USP methods and established procedures that follow cGMP guidelines and demonstrate outstanding aseptic techniques. Demonstrate high proficiency level on tests performed. Additional work duties or responsibilities as evident or required. Performs other duties as assigned or apparent.

The QC Final Test Technician is responsible for QC testing of final production Instruments. In this position the QC Final Test Technician will assist in maintaining manufacturing equipment, train others, may be asked to contribute to projects, and trained to work in several areas as needed. This role requires a self-starter, with the ability to work independently, understand of departmental goals, and work as a team to achieve those goals within set timelines. Carry out work in accordance with defined Quality Management System procedures and be fully supportive of Quality initiatives.

Responsibilities as a research associate include; Maintain human pluripotent stem cells and differentiated cells. Perform stem cell differentiation into neuronal lineages using a large variety of formats, from 384 well plates to regular and large scale culture vessels. Develop screening cell based assays using automated liquid handler for stem cell differentiation optimization. Utilize High Content Screening (HCS) technology for high-throughput analysis of cell populations. Characterize differentiated cells using a panel molecular biology methods (immuno cyto-chemistry, Flow cytometry, RT-QPCR).

NGM Biopharmaceuticals, Inc. is seeking a highly motivated Research Associate to join our Nonclinical Safety development group. This will be a temp to full time position. Needed skills include: NGM Biopharmaceuticals, Inc. is seeking a highly motivated Research Associate to join our Nonclinical Safety development group. This will be a temp to full time position.. Ability to accurately record data in study files. Excellent interpersonal skills, ability to work collaboratively and develop relationships with key stakeholders

Execute chemical processes for preparation and delivery of clinical candidates. Follow instructions in protocols and development batch records. Prepare reagents for chemical processes. Work with process development scientists and team leaders to execute process development experiments. Adhere to all environmental health and safety policies. Establish working relationships with project teams to satisfy demanding process development timelines

Position consists of manufacturing of medical components in a clean room environment while under general supervision in accordance with specifications and written procedures. This position may include machine operation, manual production using hand tools, visual inspection, physical measurements, and packaging of finished product. This position requires the ability to work with small and delicate components using a high degree of dexterity and accuracy. This position requires direct contact with medical grade components.

Position consists of manufacturing of medical components in a clean room environment while under general supervision in accordance with specifications and written procedures. This position may include machine operation, manual production using hand tools, visual inspection, physical measurements, and packaging of finished product. This position requires the ability to work with small and delicate components using a high degree of dexterity and accuracy. This position requires direct contact with medical grade components.

Evaluates mechanical and electromechanical systems and products by designing, applying principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials. Develop mechanical and electromechanical products by studying customer requirements. Design custom equipment based on standard products. Identifies, analyzes and resolves a range of complex problem types.

Performs machining duties and operations to include all set-ups and calculations to complete jobs independently and to meet prescribed specifications and requirements.

As a quality engineer you will: Assure optimum quality in manufactured products in accordance with Company standards and contract requirements.

The Packaging Technician performs routine packaging operations for the production of pharmaceutical products; operates packaging line equipment according to established SOPs and department procedures. Prepares and cleans room, equipment, facility and documents for manufacturing and packaging process. Verifies calculations, process steps and yield. Ensures that processes, tools, products and materials meet established quality standards and requirements

The Formulation Operator will work on our First Shift and perform batch processing of various calibrators, controls, and additional reagents required to support company produced and OEM analyzers. Essential Responsibilities: formulation of various solutions including staging of tanks, weighing and mixing of chemicals per assembly procedures (AP's) and final batch adjustment and transfer of solutions. Perform incoming inspection of raw chemicals upon receipt, maintenance of formulation equipment and cleaning as needed. Ability to accurately document and complete records of batch formulations.

Responsible for providing a high level of animal care and husbandry, performing regularly scheduled facility maintenance tasks, and contributing technical assistance to research projects in the NNRC rodent facility. Reports to Manager, Animal Research. Internal relationships include working with Animal Technician, Attending Veterinarian, Lab Operations Specialist, Research Associates and Research Scientists locally and globally.

The Phlebotomist will perform highly skilled, rapid-draw venipuncture and process collected biological samples according to Standard Operating Procedures (“SOPs”), sample collection and processing instructions; verify, pack and ship samples to appropriate facility.

The Phlebotomy Supervisor will be responsible for supporting study progression according to the study protocol and Standard Operating Procedures (SOPs).  Also responsible for supervising the phlebotomy staff; performing rapid venipuctures, processing biological samples and providing proper documentation and verification of the same.  Will label and prepare study supplies; ensure lab areas are prepared and cleaned and will review lab and tech instructions prior to study start up.  Will perform document and QC documentation of all study activities as assigned.  Verify, pack, coordinate and manage sample packaging and shipment/delivery to analytical labs.  Will perform practical testing for phlebotomy candidates and work with manager to train and schedule staff.

Primarily responsible for repairs and scheduled maintenance of production machines and equipment. Also responsible for fabrication of needed parts and modifications to existing machines and equipment. Assists with training manufacturing associates to do preventive maintenance on applicable machines. Performs repairs on machinery and equipment as necessary. Performs PM’s on all manual equipment. Completes all necessary forms listing work done, parts used, parts needed, time involved, etc. Initiates requirements for machine parts and supplies. Performs installation and setup of new equipment as necessary. Installs and maintains air system. etc.

Provide administrative support to Facility Manager and general office support to other business processes on site. Manage all aspects of office administration for smooth operation of facilities and comfortable, productive environment. Respond to all assignments and requests timely and efficiently; maintain discretion on all confidential or sensitive matters. Support corporate safety directives, policies and procedures; proactively contribute to wider HSE and housekeeping improvement goals. Uphold culture of camaraderie and employee engagement while promoting appreciation, trust and respect. etc.

This position requires a person to set up and operate CNC and manual machinery to manufacture medical components from raw material in a team based environment. Must be able to comply with all governing rules including S.N.E. policies and procedures and adhere to safety and cleanliness practices in the work place. This position works under minimal supervision. ESSENTIAL FUNCTIONS: Position Functions: Machine medical components, including but not limited to: Perform moderate set ups and operate CNC and manual metal fabricating equipment, including turning, milling, grinding, drilling, tapping, EDM and honing.

Performs laboratory tests to determine physical characteristics of materials and products for such purposes as quality control, process control or product development by performing essential duties and responsibilities. ESSENTIAL DUTIES AND RESPONSIBILITIES: Perform testing in accordance with relevant specification(s). Follow daily work assignments relative to test schedule. Have detailed understanding of test methods and specifications. Be able to perform basic calculations from tests. etc.

Position is expected to perform a variety of routine tasks in support of the conduct of normal laboratory operations. Further, the individual is expected to assist in coordinating testing requirements with supporting departments (i.e. chemistry staff, Quality Assurance and reporting). Performs a variety of routine, laboratory-based procedures. Responsible for understanding and routinely performing Standard Operating Procedures, study-specific protocol procedures and other laboratory assignments related to the testing that the individual is routinely associated with. Incumbent is able to apply a collective set of SOPs in order to assist in fully executing a study protocol. Often, duties include recording instrument and apparatus readings, making observations of various biological effects in exposures and compiling study data books. etc.

SUMMARY: Checking compliance of products to meet industry or client standards. ESSENTIAL DUTIES AND RESPONSIBILITIES: Sets up, adjusts, and operates laboratory equipment and instruments. Tests samples of manufactured products to verify conformity to specifications. Records test results on standardized forms, and writes test reports describing procedures used. Calibrates laboratory instruments, and mounts tires. Must have good attendance and attitude. Must be able to follow directions well. Must be able to learn quickly. Must follow all safety requirements and procedures.

Essential Position Responsibilities: Receive, check-in and dispose of study samples according to established guidelines and SOPs. Complete all appropriate paperwork in a timely fashion. Identify and document all discrepancies between client paperwork, Watson LIMS, and sample vials. Notify sponsor and Project Team of the discrepancies. Assures proper storage conditions for sample types. Accessions specimens using automated and manual systems. Use Watson LIMS to set-up shipments and receive shipment samples. Use Watson LIMS to edit subject ID information and assign custom IDs. Prepare sample disposition notifications. etc.

The Financial Analyst will provide financial and commercial decision support. The individual holding this role will be required, with some guidance, to monitor the financial impact of his/her business function against plan and provide reliable and timely analysis to guide the business leaders in their decision-making process. Duties & Responsibilities: Provides financial support to the business function, under guidance of the Business Partner, or Regional Business Partner. Supports the annual budgeting and forecasting processes. Monitors key performance indicators and interprets financial and operational performance. etc.

The Group Leader is responsible for successfully leading the department’s day-to-day activities (people/equipment/processes) with regards to safety, quality, customers, and efficiencies. Duties & Responsibilities: Demonstrate leadership and accountability in providing and sustaining a positive safety culture. Provide support for safety training, meetings, and programs. Provide recognition for safe behavior through position observations. Ensure proper instruction is provided on responsibilities and safe job performance (on the job training). Provide support for safety training, meetings, and programs. etc.

Position’s primary role is that of First Impressions Coordinator: Greeting and coordinating credentials for guests and their hosts within Smiths Medical. They also play a role in meeting site security and facility needs. They act as site concierge for all guests and employees. Supports catering activities and conference room bookings. Associate will also provide back-up for the Mail Room Associate. Position reports to Facilities Manager. Duties & Responsibilities: Welcomes visitors by greeting them, in person or on the telephone; answering or referring inquiries. Directs visitors by maintaining employee and department directories; giving instructions. Maintains security by following procedures; monitoring logbook; issuing visitor badges. etc.

The Staff Accountant will support the Controller with all accounting, finance and administrative duties. Key Duties & Responsibilities: Responsible for maintaining the integrity of General Ledger accounts, structure and cost elements. Ensure monthly financial closings are in line with expectations (on time and on quality); coordinate GL resources to work according to plan (timetable, deliverables). Ensure timely and accurate financial reporting to internal/external customers (Controlling, Auditors and others). etc.

Key Job Responsibilities: Conduct routine analysis on collaborator data as it is generated by the service lab, applying standard quality assessment protocols, and providing results to collaborators. Use internally developed and off the shelf tools to process collaborator data into standard results. Apply standard quality assessment protocols to results generated and coordinate with laboratory personnel regarding assay quality and protocol deviations. Monitor and manage data flow for collaborator samples, providing regular feedback to project management. Participate in study planning calls with collaborators to discuss how their samples will be analyzed and provide recommendations based on documented best practices. etc.

WHAT WE ARE LOOKING FOR: We are looking for enthusiastic and talented individuals who thrive on challenge and change, who can roll up their sleeves, put on multiple hats and have a can-do attitude without a lot of oversight or instruction. We are currently seeking a Manufacturing Associate who will be responsible for performing Upstream manufacturing tasks. Including but not limited to: Tracking & control of raw material inventory. Maintenance and operation of equipment in cGMP facilities. Preparation of buffer and media. Assistance in operation of single use bioreactors for production of clinical and commercial products.

We are currently seeking a Manufacturing Associate responsible for performing downstream manufacturing tasks including 1) tracking and control of raw material inventory 2) maintenance and operation of equipment in cGMP facilities, 3) buffer preparation, 4) assist in setup and operation of purification equipment for production of clinical and commercial products. etc.

This individual contributes to general operations and testing for the Quality Control and Microbiology Laboratories. This position supports in-process testing and drug substance and drug product release and stability testing programs. Works independently under general supervision. ESSENTIAL DUTIES AND RESPONSIBILITIES: Routine Environmental Monitoring in aseptic manufacturing environment” active air sampling, non-variable particulate monitoring, surface and personnel sampling. Incubation and counting of plates. Bae knowledge of microbial organisms and microbiological techniques. etc.

The Scientist will: Cell banking and quality testing of prepared batches. Isolation and cryopreservation of PBMCs in the context of clinical and pre-clinical studies. Maintain cell culture facility and culture cell lines as required for experiments including but not limited to: cell expansion, cell feeding, harvesting, counting and freezing. Participate in sample management activities such as receiving, processing, storage and shipping of clinical and preclinical samples. Participate in instrument maintenance and qualification. Maintain accurate, timely and detailed records of work. With guidance and supervision from the supervisor, conduct clinical and preclinical sample analysis per SOPs and generate data with high scientific quality to meet GLP regulatory expectations. etc.

Spherotech, Inc. seeks a college graduate for a Technical Customer Support Representative opening. Duties include, but are not limited to providing customer/technical assistance and Microparticle application support. Responsibilities also include representing the company through trade shows, technical publications, and presentations. Required laboratory skills include: Analysis of Microparticles using particle sizers, flow cytometry, fluorescence spectrophotometry, and microscopy.

Spherotech, Inc. seeks a college graduate for a Quality Control Associate opening. Duties include final product inspection, documentation, Quality Control testing etc. This position requires a Bachelor's degree in Chemistry or related field and a minimum of 1 year of experience. We offer excellent benefits including paid vacation, health insurance, dental insurance, etc. Compensation commensurate with experience.

SQZ Biotechnologies is looking for a highly motivated, collaborative, and dynamic Research Associate for our Immunology team within R&D. This role is an opportunity to focus on developing novel immunotherapies for the treatment of cancer. The scope of this work will encompass the design and execution of in vitro and in vivo experiments for internally- and externally-focused research programs. This position requires effective collaboration across multiple groups and the regular presentation of scientific results to multidisciplinary teams. etc.

MAIN JOB RESPONSIBILITIES / COMPETENCIES: Thorough knowledge of all applicable SOP's: makes proper decisions in line with applicable SOPs and standards under normal conditions. Perform highly technical tasks in support of manufacturing including equipment set-up and manufacturing of product, tool changes, sterilization processes, and filtration of material and calibration activities as assigned. Troubleshoot issues on equipment and assist with preventative maintenance. Edit equipment programs (as required). Assist in revising procedures related to operation and preventative maintenance. Support qualification activities (as required). Train production operators in the processes. Other duties as assigned. etc.

The QC Data Review Specialist will be responsible for GMP review and comment on laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP standards. ​Responsibilities: Review of documentation generated during method validation, method verification, stability testing, routine testing and other analyses. Review documentation, results and reports from raw material and finished product analysis for accuracy and completeness. Provide feedback from reviews to analysts and supervisor and ensure necessary action are taken to correct or prevent error. Review data using a systematic approach to ensure compliance with procedures and specifications. Review and audit projects as required. Perform other duties assigned by supervisor as needed. etc.

Manufacturing of Life Science products according to standard operating procedures and work instructions. Performs simple calculations according to procedures, and maintains accurate records of work performed according to GLP, GMP, and QSMRs. Independently prioritize work assignments and consistently demonstrate the ability to perform assigned tasks in manufacturing setting. Typically receives minimal instruction on routine work; general instructions on new assignments. Maintain a high level of productivity in the laboratory setting while following Good Laboratory Practices (GLP) Maintain a safe, pleasant and efficient work environment. Collaborate with other departments in process improvement or new product launch projects. Participate in special projects and department meetings via input, feedback and execution of assigned tasks. Manufacturing of Life Science products according to standard operating procedures and work instructions. Performs simple calculations according to procedures, and maintains accurate records of work performed according to GLP, GMP, and QSMRs. Independently prioritize work assignments and consistently demonstrate the ability to perform assigned tasks in manufacturing setting. Typically receives minimal instruction on routine work; general instructions on new assignments. Maintain a high level of productivity in the laboratory setting while following Good Laboratory Practices (GLP) Maintain a safe, pleasant and efficient work environment. Collaborate with other departments in process improvement or new product launch projects. Participate in special projects and department meetings via input, feedback and execution of assigned tasks. Manufacturing of Life Science products according to standard operating procedures and work instructions. Performs simple calculations according to procedures, and maintains accurate records of work performed according to GLP, GMP, and QSMRs. Independently prioritize work assignments and consistently demonstrate the ability to perform assigned tasks in manufacturing setting. Typically receives minimal instruction on routine work; general instructions on new assignments. Maintain a high level of productivity in the laboratory setting while following Good Laboratory Practices (GLP) Maintain a safe, pleasant and efficient work environment. Collaborate with other departments in process improvement or new product launch projects. Participate in special projects and department meetings via input, feedback and

This position supports Facilities GxP (GMP & GLP) compliance by acting as a liaison between Facilities, QC, GLP and QA. This position is responsible for supporting Facilities related incident investigations, CAPA, CAPA effectiveness, audits and other Quality System activities. This position supports the Master Equipment File (MEF) system by providing oversight of the document filing system. This position helps maintain departmental training compliance by providing administrative support. This position may help support validation by assisting with periodic reviews and other qualification activities. Drafts Facilities SOPs and work practices.

The successful candidate will be responsible for developing novel synthetic routes and chemical processes for anti-cancer drugs and proprietary drug linkers used for antibody conjugation. The ideal candidate should possess an in-depth knowledge of organic chemistry, reaction mechanisms, and familiarity with modern synthetic methods and analytical techniques. Candidates will have demonstrated creativity and independence in solving synthetic problems and ultimately developing robust chemical processes which he or she will work to transfer to CMO’s. Experience and expertise in peptide synthesis is desirable. Responsibilities: Conduct route scouting studies to establish novel synthetic routes for drug linkers and active pharmaceutical agents. Design and execute experiments which define parameters for robust and efficient chemical processes. etc.

Laboratory Bench Position that performs routine release testing for raw materials, intermediates, and final products within a cGMP environment. PRINCIPAL DUTIES AND RESPONSIBILITIES: Perform testing of raw materials and products. Perform instrument qualification and maintenance. Perform test method validation/verification. Review analytical data for completeness, accuracy, and compliance. Perform training on procedures, equipment, or quality systems. Other duties as assigned. Individual contributor, but may be assigned as a project lead or trainer commensurate with experience or expertise. etc.

The position will hold responsibility for assisting in the manufacturing of Sedia’s immunoassay product lines encompassing lateral flow and ELISA test. The holder of this position is expected to follow the guidance of their direct supervisor to assist in delivering company products in a timely and cost effective manner. The position will contribute in building product subassemblies or final assemblies. The Manufacturing Technician will adhere to all applicable regulations, policies, and procedures for health, safety, and environmental compliance.

Seer is seeking a Research Associate, Assay Development, who will implement and contribute to the design of biochemical experiments that support the development and operation of the company’s protein assays. These assays form the foundation of breakthrough products and services in proteomic data, which Seer will provide to patients and clinicians. The Research Associate, Assay Development will report to the Senior Scientist of Assay Development. The specific assays developed for Seer will leverage nanoparticles, immunoassays, as well as the use of mass spectrometry as a detection approach. The successful candidate is expected to have a background in biochemistry, biology, or pharmacology with experience in academia and/or industry, ideally within life sciences companies. Experience in industry, including the implementation of SOPs and testing in support of clinical or pre-clinical products is strongly desired. This role will be based in the South San Francisco office through late 2019. Please note, the company is moving to its permanent location in Redwood City at the end of the year.

Initiates, directs and executes pre-clinical scientific research and/or development strategies in research and/or development. Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems. Plans and executes laboratory research. Maintains broad knowledge of state-of-the-art principles and theories. May act as spokesperson on corporate research and development and advise top management. May participate in development of patent applications. Interfaces with various departments and serves as internal consultant. etc.

The Research Associate will be responsible for designing, executing and interpreting experiments and analytical procedures under general supervision. Opens a New Window. Initiates, directs and executes pre-clinical scientific research and/or development strategies in research and/or development. Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems. Plans and executes laboratory research. Maintains broad knowledge of state-of-the-art principles and theories. May participate in development of patent applications. Interfaces with various departments. Responsibilities: In consultation with supervisor or manager, designs procedural and experimental approach to meet designated scientific objectives. Initiates and develop plans to ensure the timely completion of several sets of experiments. Performs complex analytical procedures using established techniques.

Sekisui XenoTech, LLC is currently hiring for a Research Assistant for our Enzyme Incubations Team within the Program Execution department. The Research Assistant assists with routine laboratory functions including diluting, labeling and dispensing of biological samples, reagent solution preparation, equipment repair, laboratory upkeep, maintains inventory of supplies, and various other responsibilities. Essential duties and responsibilities include, but are not limited, to the following: Design and conduct routine and atypical experiments. Maintains laboratories and equipment and performs minor repairs on equipment, with supervision. Maintains appropriate logs, records and study notebooks. Processes and reviews data. Adheres to Good Laboratory Practice regulations and Sekisui XenoTech safety policies and procedures. Sekisui XenoTech, LLC is currently hiring for a Research Assistant for our Enzyme Incubations Team within the Program Execution department. The Research Assistant assists with routine laboratory functions including diluting, labeling and dispensing of biological samples, reagent solution preparation, equipment repair, laboratory upkeep, maintains inventory of supplies, and various other responsibilities. Essential duties and responsibilities include, but are not limited, to the following: Design and conduct routine and atypical experiments. Maintains laboratories and equipment and performs minor repairs on equipment, with supervision. Maintains appropriate logs, records and study notebooks. Processes and reviews data. Adheres to Good Laboratory Practice regulations and Sekisui XenoTech safety policies and procedures.

The Research Associate's primary role is to conduct in vivo and in vitro studies to advance Selecta's drug discovery programs. Position participates in designing and executing experiments aimed at evaluating the efficacy of Selecta's nanoparticles in relevant disease models and understanding the mechanism of action of drug candidates. The position is approximately 80% lab and 20% non-lab work. Primary Duties and Responsibilities: Plan the scheduling and designing of experiments to evaluate the efficacy of nanoparticles and understanding the mechanism of action of drug candidates. Participate and sometimes take a lead role in executing animal experiments including injections and processing tissue and serum samples. etc.

Semma Therapeutics, a biotechnology company focused on developing a pluripotent stem cell-based cell therapy for Type 1 diabetes, is seeking an outstanding research associate to join its growing team. The full-time role will focus on tissue culture, molecular and cellular characterization, process and assay developments. Under the supervision of a Principal Scientist and working closely within the Cell Biology department on novel R&D programs, the associate will be responsible for the day-to-day execution of specific projects. The position will be located in Cambridge/Boston, MA. Responsibilities: Culture and differentiation of human pluripotent stem cells in various conditions, including differentiation protocol optimization. Co-design and help execute well-controlled in vitro experiments to demonstrate technological feasibility and improvements for characterization of cell product and/or achieve proof-of-concept. etc.

We are looking for a full-time Staff Accountant to support the finance team with all aspects of the day to day accounting function as needed. The ideal candidate is ready to work hard, have fun, and utilize their technical skills to further develop their accounting career. This is an excellent opportunity where you will gain valuable experience and have impact in multiple facets of operational accounting and related tasks in a publicly traded, dynamic, rapidly growing business. Qualifications: Record accounting transactions following Senseonics internal control processes. Perform account reconciliations and close procedures. Support the preparation and analysis of monthly and quarterly results. etc.

In this Systems Engineer role, you will support moderate to complex systems engineering projects, obtain requirements, and develop new requirements based on customer needs. You will also translate requirements into detailed systems/product specifications and participate in systems analysis as well as systems/product validation and verification. You will provide technical support to systems/product users and other partners, providing resolution to engineering problems (HW, SW, Test) and implements system improvements and reports on the effectiveness of existing and new systems/products. Responsibilities: Participate in rotational exposure to all aspects of R&D life cycle to understand products; customer requirements and interface of hardware/software and system integration. Prepares test and diagnostic programs, designs test fixtures and equipment, and completes specifications and procedures for new products under direct supervision. etc.

The ideal candidate will be someone with an exceptionally strong fire alarm system background and be able to fulfill all the required duties of a Fire Alarm Installation Technician. Responsibilities: This candidate must possess strong written and verbal communication skills, have exceptional computer skills, and have a strong sense of self reliance. Must possess the ability to install, program and troubleshoot complex networked fire alarm/mass notification systems with limited or no supervision. May require some overtime hours at night, on weekends and at a moment’s notice for emergency calls. Exceptional work ethic and attention to detail.

We're looking for dedicated people wit the skills and vision to build a better tomorrow. Join our team as an Operator and you will use micrometers and other measuring tools to repair large, 500 pounds to 10 tons, rotating equipment. The majority of your work is lathe work for shaft repair. You will also do mill work to make specialty items necessary for the repairs. All your work is performed to tight tolerances. The primary purpose of this position is to operate a variety of machine tools according to manufacturing and engineering specifications and/or set-up less complex (i.e. saws, straddle mills etc.) machine tools. etc.

Now’s our time to inspire the future of healthcare together. Join our team now at Siemens Healthineers as Pharmaceutical Tech 2. This is a role well suited to an ambitious professional, looking for the next step in their career. As a Pharmaceutical Tech 2 – in production, you will be responsible for: Formulating and testing reagents and calibrators by following production worksheets and area procedures. Drug Enforcement Agency (DEA) background check clearance is required. etc. Responsibilities: Formulates and test reagents and calibrators for Atellica, Syva, Advia, Immulite and OEM product lines. Follows area procedures and manufacturing work instructions. etc.

This position is responsible for the general repair of hosiery knitting machines to ensure first quality products are produced to company specifications. Performs required/needed maintenance knitting machines to ensure machines are operating in good working order. Addresses machine stops to keep machines operating efficiently. Performs preventative maintenance as outlined in weekly PM sheets. Follows proper procedures to ensure product is knit to specifications. Sets up and sizes different styles/series on machines and ensures proper sizing to spec before released to production. etc.

The ideal candidate will have a passion for animal welfare and a great work ethic. Hard-working individuals looking for a great environment and a chance to make a difference will fit right in. Your primary role will be taking care of our animals and sanitizing their housing and our buildings. This may include caring for rats, mice, rabbits, dogs, cats, swine, or even cattle! There may be some heavy lifting and some dirty work involved but, if you love the idea of spending your day with animals, it's worth it to take care of our little heroes.

Reporting into the Quality Department, this role has responsibility for Quality related actions in support of New Product Development (NPD, Design Quality). Works collaboratively with project team members to develop and manage project plans. Champion design control and risk management activities for assigned projects. Evaluate risk and verification implications for purposed post launch design changes. Continuously improve Design Control procedures and maintain procedural compliance. Supports new product development and implementation of new products via development of an overall quality plan, including needed inspection, test, and audit procedures; identification of needed reliability testing; identification, procurement, and maintenance of needed engineering test equipment; and support of process/product validation. Responsible for development and release of engineering design documentation. etc.

We are currently seeking a Lab Assistant to provide assistance to our technicians and scientists. Responsibilities include: Carry out a number of procedures including preparing samples for analysis, sterilizing equipment, and general cleaning duties. Maintain working order of equipment and supplies necessary to perform analysis of food samples. Work closely with other team members and with the support of a department supervisor

Work as a member of a team to receive and log in client samples to prepare them for analysis. Review samples and documentation to assign identification numbers and enter data into our tracking system. Prepare packages for shipping and pick up by vendors. Contact clients when necessary to confirm information about test codes and sample contents. Achieve accurate, timely and consistent results to ensure samples are processed correctly

The incumbent is responsible for performing chemical analysis on food/pharmaceutical samples. The incumbent analyzes the concentration of certain components in food samples. The incumbent must accurately prepare and process the samples to obtain the needed results. This position reports to the Supervisor of Chemistry.

Work as a member of a team to receive and log in client samples to prepare them for analysis. Review samples and documentation to assign identification numbers and enter data into our tracking system. Prepare packages for shipping and pick up by vendors. Contact clients when necessary to confirm information about test codes and sample contents. Achieve accurate, timely and consistent results to ensure samples are processed correctly

The Biomedical Engineer is responsible for facilitating the transfer, scale-up, and validation of new and improved product designs and processes into manufacturing. Also responsible for assisting and providing technical product support for other functions including regulatory, quality, manufacturing, clinical, marketing and sales.

This role is responsible for executing daily activities in the QC Laboratory including support testing for the production of Merz North America product. Oversee and/or assist with tasks related to the activities associated with operation of Merz Quality System and as directed by Quality Management. Support all activities related to analytical assessment of Merz NA products and the manufacturing environment. Advise Quality Assurance, Manufacturing and MS&T departments on matters related to analytical testing and support. Provide direct support to Quality Assurance personnel regarding operation of the department and Quality System.

The Production Control Technician I is responsible for assisting in the control of production, documentation and inventory maintenance for multiple groups within Consumable Operations.  The position will help standardize and improve documentation, manufacturing procedures and processes to increase production efficiency and ensure best practices are followed.  The position will also help implement new products, projects and processes within Manufacturing Operations.  Some degree of professional latitude, creativity and self-management is expected.

Responsibilities will include various system engineering activities for the PTS-250 development, including, but not limited to: 1. Responsible for design, development, integration and testing of various tasks in support of the PTS Software development effort. 2. Work with engineers from the various project teams in order to develop the PTS-250 software. 3. Work with quality engineering to develop test plans. 4. Responsible for design documentation.Responsibilities will include various system engineering activities for the PTS-250 development, including, but not limited to: 1. Responsible for design, development, integration and testing of various tasks in support of the PTS Software development effort. 2. Work with engineers from the various project teams in order to develop the PTS-250 software. 3. Work with quality engineering to develop test plans. 4. Responsible for design documentation.Responsibilities will include various system engineering activities for the PTS-250 development, including, but not limited to: 1. Responsible for design, development, integration and testing of various tasks in support of the PTS Software development effort. 2. Work with engineers from the various project teams in order to develop the PTS-250 software. 3. Work with quality engineering to develop test plans. 4. Responsible for design documentation.

The technician's main duties are to ensure timeliness of testing, meeting client requirements. The technician must provide services that are compliant to the ALG-West Coast Quality Manual, client requirements and regulatory requirements as applicable such as ISO/IEC 17025:2017, USP, EU, GLP, GMP, FDA and ICH guidelines.

A Production Associate is a multi-skilled employee that will perform a variety of duties to support the assembly of rescue tools and other products. Production Associates will perform a variety of activities including (but not limited to) material handling, stocking parts, quality inspections, and packaging products for shipping. Responsible for maintaining established quality standards while ensuring a safe and clean work environment.

There are two openings. These positions are responsible for basic and routine tasks involved in the manufacture and assembly of the company's disposable test cartridges. Follow written procedures for set-up, operation, and clean up of manufacturing equipments, final assembly, and packaging. Responsible for manual tasks including, pipette solution, pouch and box labeling, product inspection. Prepare materials used in the cartridge production process.

Manufacture or evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department. Manufacture or evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department. Ensure quality throughout the process. Assure you are adequately trained to perform tasks/assignments. Perform routine assays, processes and/or unit operations. Contribute to support functions of the lab (e.g., maintain equipment, prepare reagents, restock lab supplies, waste disposal).

Perform all routine and relevant laboratory techniques in compliance with BioReliance regulatory standards.  Maintain and operate all laboratory equipment with some troubleshooting, as required.  Perform various cell culture operations for biosafety testing.  Maintains thorough records in addition to peer review of batch records.  Responsible for generating deviations as required and participating in resolving investigations with support of other team members.  Maintains a standard up keep of the facility through daily cleaning.  Actively performs equipment and general housekeeping daily checks and notify relevant personnel of any issues.  Initiates and completes projects independently, including troubleshooting during routine laboratory activities.

The purpose of this position is to Initiate and expedite the transfer of inventory from and to related parties. Ensure that all materials, equipment and tools are available for production and maintenance of site processes. Solicit price and delivery information from vendors, enters into computer files and communicates to appropriate departments. Coordinate with other departments the procurement of tools, materials and equipment.

The Manufacturing Technician I position will work in a cleanroom environment and adhere to cGMP batch records and SOPs to support the manufacturing of viral vector products. Employees will support projects in conjunction with other GMP Manufacturing personnel (Leads, Supervisors, Managers). Employees are expected to prepare suites for manufacturing, to document deviations, and to operate in a safe and compliant manner.

You will apply your GLP/GMP experience to perform and maintain cell cultures using aseptic techniques. Ideally, you will be able to order materials and maintain inventory with the goal in mind that every effort is aimed at developing and qualifying processes required for clinical cell and gene therapy products. In addition to your primary responsibilities, you will document activities for reproducibility, clean and maintain laboratory equipment and support team members as needed.

As a member of the Miltenyi Biotec team, you will help ensure that the shipping and receiving process runs efficiently for our growing biotechnology organization. You will prepare and process inventory using your Enterprise Resource Planning (ERP) and shipping systems knowledge. In addition, you will record and receive incoming shipments according to established SOPs, as well as prepare and process shipments according to international regulations. There will also be occasion for employing hand-trucks and forklifts in order to move and store certain articles during routine inventory maintenance.

he Shipping Associate will pick orders from inventory and prepare them for shipping in an accurate and timely fashion. The Shipping Associate is also responsible for assembling finished goods for entry into inventory. This position will report directly to the Shipping Manager. Prepare and execute domestic and international shipping of Mirus products using FedEx, UPS, DHL and freight forwarders. Assemble finished goods for inventory. Follow departmental Standard Operating Procedures (SOPs)

Moderna is seeking a highly skilled and motivated Engineer I/II in Sterile Product Technology, a process development team residing in Moderna’s Technical Development organization, to support mRNA lipid nanoparticle (LNP) process development that enables our clinical supply. The applicant will play a critical role helping bring medicines to patients as Moderna’s portfolio begins to shift towards late-stage development. The primary role for this position will be to support fill/finish process development and scale-up work, with eventual ownership of experimental design and execution. The applicant will collaborate closely with Technical Development, Pre-clinical and GMP Production, Quality, and Drug Product Analytical Development groups on innovative process development efforts. Applicants should have relevant pharmaceutical experience with fill/finish processes and drug product development.

The primary responsibilities of this role will be to support implementation of analytical methods and routine testing messenger RNA therapeutic drug substances and drug products, including both chemical separation and biophysical techniques.  The incumbent will be expected to undertake laboratory work to support in-process sample testing of critical non-GMP large scale batches including IND enabling drug substance and drug product batches.   The analyst will be responsible for generation and reporting of analytical results.  

The individual in this role will be responsible for production of DNA for all constructs using custom automation, Hamilton liquid Handlers, and chromatography solutions. The successful candidate must demonstrate the ability to quickly master new processes and the drive to be part of a dynamic, fast paced, and highly motivated team. They must have training in chromatography (UPLC/HPLC), liquid handlers, basic molecular biology techniques, and ability to work with custom automation. The anticipated time frame for this assignment is 6 months.

Molecular Templates is seeking a highly-motivated and skilled Research Associate to support research and development activities. The position will be primarily responsible for ETB protein production and analysis in accordance to established protocols, and performing general laboratory duties, including solution and media prep, labware sterilization, ordering supplies, and maintaining inventory and basic laboratory equipment. This position will require excellent technical, analytical, time management and organizational skills, along with adherence to written and verbal instructions and accurate and timely completion of documentation.

Molecular Templates is seeking a highly-motivated and skilled Research Associate to support downstream processing for Protein Sciences. This position will perform functions related to production of pre-clinical drug product and early-stage process development for protein sciences, including routine protein purification, equipment maintenance checks and calibration, data management, and assist in review and development methods and procedures to control or modify the process. This position will also aid in identifying continuous process improvement areas.

Molecular Templates is seeking an experienced and highly-motivated professional to support downstream processing for manufacturing activities. This position will perform functions related to production and manufacturing operations, including routine protein purification, equipment maintenance checks and calibration, data management, and assist in review and development methods and procedures to control or modify the manufacturing process. This position will also aid in identifying continuous process improvement areas.

The successful candidate will join a dynamic, multi-disciplinary team of scientists, playing a key role to evaluate new immunotherapeutic strategies and drug candidates. The candidate is expected to be multi-tasking and able to execute experiments with strong attention to detail under supervision.

. The successful candidate will work both independently and collaboratively as part of the Cell Biology team. Perform a diverse range of cell-based assays to characterize lead candidates for various therapeutic mechanisms. Expand and differentiate human iPSCs towards the cardiovascular lineage. Execute a range of experiments using molecular biology and cell biology techniques including nucleic acid and protein isolation, qPCR, virus preparation, and metabolic assays. Manage aspects of housekeeping for the cell culture lab, including preparing reagents, helping with room maintenance, ordering and restocking.

You will be responsible for identifying and driving all digital content creation (Amazon A+/WebCollage, optimized copy, enhanced images and videos, Brand Store pages and Brand campaigns) for new and existing items across key brands. Assist sales teams for eTail such as Amazon, Walmart.com, Target.com, Costco.com to ensure content is optimized to achieve “best in class” ratings, using scorecards provided by tools such as Clavis as well as key customer dashboards. Research competitive data to understand current industry trends in order to stay competitive and develop best practices for E-Commerce content as it pertains to site merchandising and the online user experience. You are supposed to represent the end consumer and bring in their perspective and insights to add value within the broader e-commerce team. You would be the main point of contact for the various Brand teams and would work closely in understanding their brand strategy and bringing it to life within the ecommerce world. etc.

Activation practitioner with experience in the media/search marketplace, who is eager to have immediate impact on RB E-Business team in its activation and optimization practice. Energized by the development of data architectures to drive performance along with executing dashboards that drive clear analysis and insights on in-market media results. Eager to create meaningful vendor partnerships & act as daily trader within self-service media platforms. ‘Hands on Keyboard’ operational activation & management of e-commerce Search/SEM strategy with stewardship of keyword, bid and pacing management Maintain relationships across Amazon AMS, AMG & Criteo Stewardship of go-to-market marketing approach across Bricks & Clicks customers, inclusive of activation of display & SEM campaigns. etc.

We are looking for graduating students to join our RB Finance Graduate Development Program. You may do rotations through: Supply Finance, Commercial Finance and Accounting. Responsibilities: Collect, process, verify, and report accounting related information. Perform professional analytical and management to support work assignments. Assist in preparing monthly financial reports, developing and/or utilizing spreadsheets, databases and other computer applications. Process specialized information, reports, and forms for fees, billing, project tracking, etc. Enter information reports into a financial accounting system. Other financial, accounting, and information system related tasks are to be performed as assigned. etc.

Proactively identifies and executes strategic analytical method development and validation initiatives to support early innovation projects, human milk research, and key quality objectives. Active participant on project teams as an Analytical Sciences representative who delivers timely responses regarding analytical questions, project deliverables, and on-going analytical support. Identifies areas of improvements for analytical methodology through utilization of new technologies and instrumentation, implementation of method validation and transfer practices, and effective networking with the internal MJN analytical community as well as external experts. Contributes to technical hypotheses regarding analytical capabilities and develops protocols to test those hypotheses. Efficiently creates and executes method validation protocols to ensure developed methods are compliant against all internal criteria. Performs instrument maintenance and repair support while building knowledge and understanding of troubleshooting methodology and instrumentation issues. Effectively communicates scientific knowledge and information to technical and non-technical audiences at multiple levels through a variety of internal and external facing formats.

The Clinical Logistics Associate I provides support to the Clinical Logistics group and IP distribution process for one or more clinical trials. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities’ regulations / guidelines and Regeneron SOPs / WPDs. Contributes to ongoing process improvement initiatives. This role applies to internally sourced studies and/or CRO/Partnered studies. Interacts with clinical trial managers, as well as staff from quality, clinical compliance, and IOPS (CMC, external manufacturing, stability). etc.

Summary: Performs all tasks necessary for the manufacturing dispensing operations. Essential Duties and Responsibilities include, but are not limited to, the following: Includes all aspects of biotech production activities related to raw material dispensing. Ensures that raw materials are dispensed as specified in Batch Sheets or Manufacturing Records to support manufacturing operations. Works with manufacturing process areas and manufacturing inventory group to schedule lots of raw materials to be dispensed. Reviews, edits, completes, and revises completed batch records (if applicable), Logbooks, and SOPs in accordance with cGMP standards and compliant with written procedure. etc.

VelocImmune (VI) Next is a technology development group at Regeneron that invents and develops state-of-the-art tools for biologic drug discovery. We are seeking a motivated, highly organized researcher to support our investigations of new antibody and cell-based therapies. This is an opportunity for a researcher with strong molecular & cell biology skills to contribute to the development of industry-leading technologies and medicines. Responsibilities: Independently and as a team, conduct and support experiments. Investigating and develop new methodologies and technologies in molecular biology and biological therapeutics. Design, construct, and test DNA vectors, viral vectors, and cell-lines for in vitro and in vivo studies of candidate biologicals. Characterization of mice via NGS (next-generation sequencing) and flow cytometry-based phenotyping. etc. VelocImmune (VI) Next is a technology development group at Regeneron that invents and develops state-of-the-art tools for biologic drug discovery. We are seeking a motivated, highly organized researcher to support our investigations of new antibody and cell-based therapies. This is an opportunity for a researcher with strong molecular & cell biology skills to contribute to the development of industry-leading technologies and medicines. Responsibilities: Independently and as a team, conduct and support experiments. Investigating and develop new methodologies and technologies in molecular biology and biological therapeutics. Design, construct, and test DNA vectors, viral vectors, and cell-lines for in vitro and in vivo studies of candidate biologicals. Characterization of mice via NGS (next-generation sequencing) and flow cytometry-based phenotyping. etc. VelocImmune (VI) Next is a technology development group at Regeneron that invents and develops state-of-the-art tools for biologic drug discovery. We are seeking a motivated, highly organized researcher to support our investigations of new antibody and cell-based therapies. This is an opportunity for a researcher with strong molecular & cell biology skills to contribute to the development of industry-leading technologies and medicines. Responsibilities: Independently and as a team, conduct and support experiments. Investigating and develop new methodologies and technologies in molecular biology and biological therapeutics. Design, construct, and test DNA vectors, viral vectors, and cell-lines for in vitro and in vivo studies of candidate biologicals. Charact

POSITION SUMMARY: Obtain, compile, track, review, file and disposition accurate and complete donor records (paper and electronic) to support applicable regulations, standards and departmental procedures for donor eligibility determination in a timely manner. Disposition donors in electronic system for release into production, rejection or Medical Director request for additional information. Develop and maintain effective working relationships with recovery agencies and other entities providing donor records to facilitate timely submission of accurate and complete required records. Act as departmental liaison to both internal and external customers to provide requested donor related information and/or resolve issues as requested. Comply with all applicable regulations, standards, company policies and departmental procedures. Support company and departmental quality and business objectives and initiatives. Provide information to develop and monitor quality and business metrics as requested.

The Tissue Tech 1 position at RTI represents an entry level function. Employees will develop technical skills in their assigned areas, an understanding of the rules and regulations that RTI administers, and the basic operating approach at RTI including: reading, understanding, and following work instructions; working in a team environment; and learning to work with minimal supervision. POSITION SUMMARY: Performs tissue processing activities that produce the highest level of quality and yield outcomes in accordance with applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs). Responsible for accurately processing tissue products and meeting production schedules. etc.

The Salix Inside Sales Associate program offers a unique opportunity for recent college graduates who are interested in a fast start to an exciting career in medical/medical device sales. We are seeking candidates who are highly competitive, have a strong work ethic and are motivated to accelerate their position in a company currently launching several new and innovative products into the GI marketplace. Those accepted into this exclusive program will relocate to Bridgewater, NJ for approximately 12 months. During the 12 months Sales Associates receive intensive training on: Products, Selling Skills, and Industry & Territory Management. Upon successful completion of the 12-month training program, Sales Associates ready for the field will be eligible to apply to any open Salix Territory Manager positions. Sales Associate pay, bonus and benefits are competitive. Upon placement into a field sales territory the Sales Associate is provided with a company car and necessary tools to manage a territory - including an iPad and iPhone. Some relocation assistance may be available depending on relocation distance. etc.

We are seeking a highly motivated and skilled scientist to join our dynamic Research Team. The Research Team leads target/enzyme-based projects for biotech and pharma clients to develop assays for high-throughput screening, and characterization of drug candidates and reaction mechanisms. The successful candidate will be organized and able to work under strict timelines in a fast paced environment. Primary responsibilities may include handling and processing of reagents and materials for running biochemical assays, designing and performing biochemical assays utilizing state of the art MALDI TOF mass spectrometry, take a project leadership role on multiple targets/enzymes, integrating automated liquid handling, and writing and maintaining Standard Operating Protocols (SOPs).

Executes stability programs to support product expiration dating, storage and handling, shipping and patient use in compliance with industry practices and regulatory requirements. Also participates in the Periodic Product Review (PPR) process. Responsibilities: Participate in monitoring stability storage conditions, submit stability samples to analytical laboratories when required and monitor laboratory test results. Participate in developing stability study protocols and in in establishing strategies for stability studies. Perform analysis of stability data and draft stability technical reports. Escalate unusual observations, deviations or any incidence of non-compliance with established protocols or procedures. Compile stability data for inclusion in regulatory submissions. Participate in the compilation of Periodic Product Review (PPR) reports. Participate directly with external departments (e.g. Manufacturing Science & Technology, External Supply Quality Assurance, and CMOs). etc.

SCBT has an immediate opening for an entry level Customer Service Representatives at its Dallas, TX Headquarters campus. This position performs telephone customer support, order processing, and data entry functions. The current shift available for this position is the early afternoon to early evenings shift, Monday through Friday. This is a full time position with career advancement opportunities within the company. Required Skills: Ability to professionally answer incoming telephones calls and effectively communicate information about products, prices, and product availability to customers. Ability to enter orders from customers in a timely and accurate manner. Ability to support the Logistics Department to ensure the timely and accurate shipment of products to customers. etc.

Santa Cruz Biotechnology has an immediate opening for an entry level Research Assistant at our Paso Robles, CA campus. This is a full time position with career advancement opportunities within the company. Required Skills: Ability to perform standard analytical and preparative procedures required for the development and analysis of monoclonal antibodies. Ability to characterize antibodies by designing and optimizing experiments, interpreting data, and selecting the best possible products to develop. Capacity to utilize established, routine procedures and follows instructions from supervisor. Strong scientific background and business communication skills.

Santa Cruz Biotechnology has an immediate opening for an entry level Research Assistant at our Santa Cruz, CA campus. This is a full time position with career advancement opportunities within the company. Required Skills: Ability to perform standard analytical and preparative procedures required for the development and analysis of monoclonal antibodies. Ability to characterize antibodies by designing and optimizing experiments, interpreting data, and selecting the best possible products to develop. Capacity to utilize established, routine procedures and follows instructions from supervisor. Strong scientific background and business communication skills.

The Research Associate will support the development of Sarepta’s Gene Therapy platform. Working as a member of Gene Therapy group within Technical Operations department, he/she will support the implementation of in-process analytical test methods for use in the development of gene therapy products. The individual will collaborate with the Analytical Development team to support the adaptation of release test methods for use in-process, will execute established test methods to better characterize product and impurities over the course of development and will collaborate with process development scientists on the design and interpretation of studies. The individual may also work with external stakeholders in supporting evaluation of processes managed outside of the organization. etc.

Primary responsibilities Include: Handle, transfer, and distribute mice, supplies and waste as needed to and from work area(s). Proficient in IM, IV, IP administration techniques in lab animals. Clean cages and racks. Monitor the daily health and welfare of the animals according to IACUC guidelines. Coordinate with vendors and supervisors on operational, administrative and technical responsibilities. Responsible for overseeing procurement of animals and supplies, preventive maintenance of facility equipment. Strong written and verbal English communication skills. Ability to follow written and verbal instructions. Follows standard operating procedures and maintains recordkeeping pertaining to equipment operation, animal and supply inventories in accordance with federal and state guidelines and regulations. etc.

Sarepta Therapeutics is seeking a motivated clinical operations specialist with experience working in clinical operations and GCP/GLP environment for a clinical operations support role. The Research Associate (RA) will assist the Clinical Research Manager in interacting with the Clinical Operations group in the planning, execution and management of clinical samples. The RA will support the transfer of clinical samples from collaborators and CROs to Sarepta and third party storage facilities. He/She will work closely with the Clinical Research Manager to facilitate the training of international biopsy surgical sites and distribution of training materials. Additionally, he/she will take on a role in tracking training documentation across studies/research protocols. The candidate must exercise discretion and judgment in handling confidential information and will follow FDA regulations, ICH guidelines and GCP in all tasks. Strong organizational skills are required, as well as the ability to balance changing priorities. The role may involve occasional travel to oversee clinical sites or vendors. etc.

Associate scientist needed in the area of pharmaceutical drug delivery research. Responsibilities include conducting laboratory experiments in support of formulation and process development. Knowledge of laboratory practices and demonstrated skills in analytical instrumental techniques (e.g. HPLC) are preferred. Excellent communication skills needed for preparing and following standard test methods and reporting experimental results.

The Manufacturing Associate Level I is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.

This individual is responsible for execution of Process Validation (PV) or for PV support with intensive supervisory direction for Liquid Media, LAL and Powder Media at the Walkersville Site. The individual performs assigned duties according to specified procedures and receives detailed instructions. The individual performs a variety of routine work within established policies and procedures, and receives detailed instructions on new projects and assignments. ble to work with intensive assistance and supervision on basic PV techniques of protocol development, execution, and reporting to ensure technical content is sufficient and accurate. This individual is expected to ask questions about content. Not approved to make protocol decisions (i.e. conclusions, product impact / validation impact assessment, and corrective actions) without review of a higher level PV scientist or Manager.

The Automation Engineer is responsible for operating and maintaining Automation/Control systems that support all Ohio facilities. The incumbent has responsibility for indirectly supervising and directing internal resources as well as contract service providers The individual will be responsible for providing Subject Matter Expertise (SME) for various Automation/Control systems including PLC’s, HMI’s, SCADA, BAS/BMS, vision systems, servo and motor controls, and associated infrastructure.

Responsible for Technology Transfer and process scale up activities associated with parenteral drug products. Supports cross-functional Production, Engineering, Quality Assurance, and Validation departments to support the trouble shooting of manufacturing issues. Conduct the experiments under the supervision of Scientists for Tech Transfer, Process R&D/Scale up/Validation, and other activities needed for introduction of a new product into cGMP manufacturing site or to support process improvements of existing products. Execute laboratory experiments as per the protocols or under supervision to study material compatibility studies and/or cleaning validation activities

The R&D Document Coordinator I will author, edit, review, evaluate, and maintain GMP documentation (RM documents, FP documents, Analysis SOPs, Validation Protocols, Technical reports, etc. and all required revisions). The individual will co-ordinate with Document Control and Change Request reviewers from the documents initiation to the approval stage. Draft Raw Material, In-Process, and Finished Product documents. Provide editorial support and ensure quality of all document content; focus on clarity, accuracy and consistency, while maintaining adherence to proper formats, regulatory requirements and company procedures and guidelines.

The position will be supporting a research biology lab actively engaged in optimizing the growth of cyanobacteria cultures. This is a full time, regular, hourly position; 40 hours per week. The work schedule is somewhat flexible, and training will be provided. Responsibilities include: Clean and maintain stocks of laboratory glassware, Maintain general laboratory solutions and other reagents, Support lab manager in maintaining stocks of consumable items, May also perform plasmid DNA purification, PCR reactions and other standard laboratory protocols

The Associate Scientist II will be responsible for: Carrying out day-to-day work in the laboratory to ensure consistent performance of new products, investigate potential product or process issues, and provide supporting data for new manufacturing processes. Planning and scheduling work independently following the technical direction of scientists and senior lab personnel and following practices, procedures and protocols of the group. Participating in the design of lab experiments, write reports, procedures and other documentation, present to interdepartmental groups, general laboratory upkeep, and mentor entry level lab personnel.

Luna Innovations is seeking a creative Electromagnetic Research/Engineering Associate to conduct research focused on the discovery and development of new electromagnetic materials technology towards commercial applications. Current areas of development in the Advanced Materials Group include electromagnetic interference (EMI) shielding composites, coatings, and sealants; radar absorbing materials; conformal antennas; and signature control coatings. It is desired that the candidate will have a background in one or more of these areas, with specific expertise in electromagnetic material properties, EMI testing and characterization, and develop skills by contributing to program management, new idea generation, and experimental design / execution. Electromagnetic modeling and simulation experience is a plus. The candidate must be a U.S. Citizen and either have a Security Clearance or be willing and able to obtain a DoD Security Clearance.

Support and help lead 3D organ scaffold printing, helping lead both internal and external development efforts to design and formulate fluidic devices, evaluate bio-inks, evaluate biomaterial properties required for lung scaffold printing. Provide hands-on reduction to practice for manufacturing of prototypes, including the use of fluidic devices, bio-materials, non-biologic polymers, coupling and cross-linking chemistry and coatings. Establish and maintain a deep understanding of current and emerging technology in fluidics, precision machining, and biomaterials. Follow existing test practices and develop additional experimental plans to achieve project milestones; understand and adhere to critical path activities, assemble equipment necessary to execute experimental plans for prototype development

Processes active compound materials into final tablet form performing quality control checks to maintain consistency of product according to manufacturing specifications. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Manufacturing Associate is expected to fully participate in both departmental projects and any quality working teams that may be applicable. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities.

This position provides day to day support assisting in areas such as GMP, ISO 9001 and ISO 17025 compliance and the company’s quality system. Duties include quality assurance and control activities in technical, systems, operations and service areas. This position may require frequent interaction with multiple departments. Works under general supervision of management or team lead.

I’m looking for a full time Remote Holter Scanner in the Burtonsville, MD area. Responsibilities include: Receiving ambulatory ECG data from web transmissions. Making the correct arrhythmia call, not just knowing where to place the electrodes. Using proprietary software to efficiently compose arrhythmia reports for physicians. Acquire and/or retain clinical certifications

The successful candidate will carry out analytical testing and method development using Electrophoresis, Chromatography, and Mass Spectrometry techniques in support of early and late stage development of biopharmaceutical products, such as humanized monoclonal antibodies, and recombinant proteins. The candidate will make detailed experimental observations, review and analyze data, interpret experimental results, and summarize data for presentations and reports. The candidate will author SOPs, protocols, reports and other relevant documentation.

The technician is responsible for the operation of equipment according to established Standard Operating Procedures and Master Production Records for the manufacture of therapeutic proteins and vaccines in accordance with Current Good Manufacturing Practices (cGMP’s). Operates production equipment such as bioreactors, centrifuges, filtration devices, chromatography equipment, washers, autoclaves, tanks. Weighs and checks raw materials, assembles and cleans process equipment, monitors processes. Performs SIP, CIP and manual cleaning and sanitization of equipment. etc.

Responsibilities include: Create orders and purchase supplies for all Medpace entities; Maintain inventory by entering and updating item information into accounting system; Work closely with vendors to build relationships and resolve issues; Reconcile open orders on a monthly basis; Support Treasury team through new vendor setup process.

Your primary role is driving conceptualization, development, and prototyping of new product concepts, focused on inventive uses of new and existing technologies that open up entirely new product concepts. Work hours and days are extremely flexible, based on need and your availability. Integrate Industrial Design Techniques to Create Designs with Improved Aesthetics, Ergonomics, and Usability. Select and Integrate Proper Materials, Components, Technologies, and Assembly/Manufacturing Processes.

Performs a variety of laboratory tests and assays in accordance with established policies, procedures and regulations in a designated technical department. Interprets results, subject to verification by Technologist/Supervisor, and providing allowance by State regulations.

We are seeking a Data Entry Lab Assistant to work in our Specimen Accessioning department. The primary function of this position is to unpack and enter all data accompanying specimens received at the laboratory to begin the testing process. Candidates must possess a passion for patient care, be goal oriented, and enjoy teamwork.

This is a multi-discipline position with 3 primary components: specimen accessioning, sample splitting/sorting and data entry. As a Specimen Processing Specialist, your responsibilities/job duties include: Preparing laboratory specimens for designated departments/locations prior to laboratory analysis and testing and routes specimens by type to various staging areas. Performing all paperwork, technical and non-technical procedures required to process and submit specimens. Operating data entry terminals and automated data systems, follows standard sequences/coding when entering data and corrects, edits, and/or verifies data entered into automated systems

Responsibilities may include the following: Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.

You will serve as an individual contributor by providing support for the new product development and sustaining projects. The individual will assist the business in interpreting and executing against Medtronic quality system elements including software/system work products to ensure compliance. This individual will ensure that all system-level project / program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic’s quality, reliability, and compliance requirements. This individual will ensure Design Quality Assurance-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes.

As an Associate Supplier Quality Engineer, you will be responsible for:  Providing support to Operations and Receiving inspection teams in all areas of production quality assurance. Ensure components received in Miami lakes meet specifications, works with suppliers to investigate root cause and provide sound corrective actions in a fashion manner. May participate in supplier process development, supplier management, and maintaining supplier files. 

Specific to Environmental and Utility Monitoring, the Analyst will be responsible for maintaining the EM program to include the following: Collection and testing of qualified Utility systems including Clean Steam, WFI and compressed gasses. Execute environmental sampling of Classified Areas including active air sampling, surface sampling and non-viable air sampling. Provide data entry, review and approval as required. Provide summaries of test results to appropriate personnel as needed

The successful candidate will be expected to work as part of a team that is focused on the development of vaccine drug products.  The main responsibilities include the design and execution of experiments to evaluate the impact of formulation composition and the manufacturing process on yield and stability of liquid and lyophilized vaccine drug products. The successful candidate will have formulation and/or process development experience with large molecules. They should possess scientific knowledge and/or experience related to biophysical characterization, lyophilization or other drying technologies, and immunology. Effective oral and written communication skills and the ability to learn new skills quickly are essential.

Under the supervision of the Laboratory Supervisor, Senior Supervisor, Area Head or Laboratory Manager, consult with supervision concerning the planning of and perform testing on raw materials, culture media, production intermediates, manufactured bulks, finished products and/or other samples in compliance with written procedures. Testing may be performed in one or more of the following scientific disciplines: Microbiology, Biochemistry, and/or Virology. Read, record, review and calculate test results and may be required to assist in the approval/validation of test data generated according to written procedures. Assist in the revision/implementation of control procedures (CPs) and standard operating procedures (SOPs) within the department and assist in training and orientation of other Laboratory Technicians.

The primary purpose of this job is to support all calibration activities relating to the development, inspection, testing and production of product. Performs calibration, maintenance, modification, and testing on diverse types of IM&TE (Inspection, Measurement, and Test Equipment) and process control/manufacturing measuring equipment. Maintains records of all IM&TE and process control manufacturing equipment used throughout facility in compliance with FDA/ISO regulations and established procedures. Generates status reports from calibration scheduling database and works to minimize late calibrations, notifies affected areas as needed.

Under the director of the area Supervisor/Team Leader, the Production Operator is responsible for production work according to specifications and established policies, procedures, practices, and standards. Follow all standard operating procedures (SOPs), Good Manufacturing Practices (GMPs), and DOIs. Assemble components. Perform bar sealing/tray sealing duties. May operate packaging machine, etc.

The position may reside in any one of the functional areas and carry out the responsibility under some supervision: Operate and troubleshoot the following instruments/equipment to test pharmaceutical samples: HPLC/UPLC, Dissolution apparatus, Karl-Fisher water content titrator, GC, FTIR, UV, Other analytical instruments as directed. Follow analytical test methods, compendial methods, experimental procedures and SOP’s. Document test results in laboratory notebook, in real-time, and communicate status of test results to supervisor. Peer review of laboratory notebooks for technical details. Maintain control of all project related samples submitted to the laboratory. etc.

The QA Coordinator plays an essential role in the management of key GXP (Good Clinical / Manufacturing / Laboratory / Pharmacovigilance / Distribution Practices) Quality Assurance records and documents, including training curriculum management and assignment and Quality Management System records such as deviations, investigations, Audits, Audit Findings, Corrective and Preventative Actions (CAPAs), vendor qualifications and inspections. Responsibilities: Maintains training requirements matrix, tracking role-based training requirements across the company. Assigns training to new and current employees according to the training matrix. Tracks and generates compliance metrics on training completion. etc.

Key Duties and Responsibilities: Conducting primer design, PCR, gel electrophoresis, Quikchange mutagenesis, restriction enzyme digestion/analysis, ligation, sequence and ligation independent cloning. Responsible for cloning constructs (antibody, therapeutic proteins, or research reagents) and purifying DNA at different production scales (Mini-, Midi-, Maxi-, Giga-) to support critical reagents needs, material generation efforts, and cell-line development activities. Responsible for ordering and maintaining raw materials, lab supplies, and providing oversight to inventory of all required working reagents. Maintain, calibrate, and troubleshoot molecular biology-related equipment. Document experimental procedures, quality control, stocking and tracking reagent inventory. Responsible for working with DNA analysis software programs such as DNAStar, Vector-NTI or equivalent. etc.

We are looking for graduating students to join our RB Supply Graduate Development Program. The program includes rotations that allow you to gain a holistic view and exposure to the entire Supply Chain function. During the rotations, you’ll be gaining valuable experience and building on functional fundamentals, as you get your feet wet with responsibilities supporting each respective function. Rotations also allow you to work in various locations throughout RB’s US offices, adding to the breadth of exposure needed to become a true success at RB! A brief description of each function is found below: Customer Service – RB’s key player in managing flow of orders and determines team ability to add value to local business. Planning (Custom Manufacturing, Demand Planning, S&OP) - Control tower of Supply Services. Serve as point of contact between RB Commercial and RB Manufacturing. Logistics (Transportation, Warehousing, Corporate Logistics) – This is where “the rubber hits the road” in terms of managing not only the key operational aspect of the Supply Services team but also the most significant costs within Supply Services. Manufacturing - Takes place in each factory; where raw and packaging materials are transformed into packaged ready products. etc.

We are looking for graduating students to join our RB Finance Graduate Development Program. You may do rotations through: Supply Finance, Commercial Finance and Accounting. Responsibilities: Collect, process, verify, and report accounting related information. Perform professional analytical and management to support work assignments. Assist in preparing monthly financial reports, developing and/or utilizing spreadsheets, databases and other computer applications. Process specialized information, reports, and forms for fees, billing, project tracking, etc. Enter information reports into a financial accounting system. etc.

A fantastic opportunity is available for a Performance Marketing Analyst to join our Marketing team in Parsippany, NJ: Activation practitioner with experience in the media/search marketplace, who is eager to have immediate impact on RB E-Business team in its activation and optimization practice. Energized by the development of data architectures to drive performance along with executing dashboards that drive clear analysis and insights on in-market media results. Eager to create meaningful vendor partnerships & act as daily trader within self-service media platforms. ‘Hands on Keyboard’ operational activation & management of e-commerce Search/SEM strategy with stewardship of keyword, bid and pacing management Maintain relationships across Amazon AMS, AMG & Criteo Stewardship of go-to-market marketing approach across Bricks & Clicks customers, inclusive of activation of display & SEM campaigns.

The Independent Pharmacy Sales Representative (IPS) is responsible for achieving sales goals and implementing company approved programs within an assigned geographically defined territory. Sales & Merchandising responsibilities include driving front end execution for RB brands. This includes driving incremental SKU distribution, display sales as well as sustaining product distribution, shelving and promotion activities for RB branded products. Duties include successful sales of conceptual products and programs to store level decision-makers while maintaining trusting relationships. Excellent selling and negotiation skills will allow you to provide compelling reasons to purchase, or display, against the competition. etc.

Analyze learning needs of internal departments, design and develop digital learning solutions for those needs, and implement them through the enterprise Learning Management System or other platforms. Essential Duties and Responsibilities include, but are not limited to, the following: Project Manage and directly Design, Develop, and Implement eLearning, learning resources (wiki, websites, manuals, job aids, etc.), and digital materials for classroom trainings; including the necessary storyboards, outlines, and project plans. Apply instructional design methodologies in creation of learning solutions and assessments. Conduct training needs analysis with internal departments to gather their training requirements. etc.

The Associate Editor will work with more senior Medical Writing Editors and Medical Writers to learn about clinical regulatory documents and the drug development process. The individual will also work with more senior Medical Writing Editors to learn how to perform a full QC check of clinical regulatory documents, to ensure that they meet company standards and Health Authority guidelines. As the individual’s QC skills, knowledge of the drug development process and knowledge of regulatory document content increase, his/her responsibilities will increase to include more editing responsibilities (eg, checks for appropriate spelling/grammar, template use, and content). The Associate Editor will focus on learning QC techniques before learning the editing processes. etc.

Essential Duties and Responsibilities include, but are not limited to, the following: Provide support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and followup/completion of documents such as Change Controls, EOE's, NOE's, DNF's, risk assessments, impact statements and corrective/prevention action plans. Participate/lead/author investigations and root cause analysis for department issues of non-compliance. Act as a liaison between engineering &Automation and onsite quality and regulatory groups to define and address compliance related items. etc.

Rejuvenate Bio is looking for a highly-motivated individual to join our energetic team and accelerate the development of our therapies. The research assistant position will directly support efforts to drive forward our future commercial offerings working with other RA's and scientists. The applicant will be performing standard molecular biology procedures as well as more advanced cell culture and virus creation. The role reports to senior or principal scientists at Rejuvenate Bio. Responsibilities will include: Following laboratory protocols and safety regulations. Performing standard cloning techniques (restriction enzyme, gateway, golden gate). Performing basic and advanced cell culture on a variety of cell lines. etc.

As an expert in single use tangential flow filtration, Repligen offers TangenX® Flat Sheet TFF Cassettes with unparalleled flexibility and scalability from process development to production scale. Since 2008, SIUS tangential flow filtration products have been universally accepted as the first purpose built single use tangential flow filtration cassette ideally suited for downstream purification operations. The individual will work in the manufacturing of novel high performance ultrafiltration and microfiltration membranes – with an ultimate goal of impacting bioprocessing biological molecules. The work will also include improvements in membrane formation processes. The work will require a good understanding of polymers and membrane formation processes. We are seeking a Membrane Engineer within the operations group to focus on the manufacturing of existing and new ultrafiltration membranes. etc.

This assembly position performs a wide variety of fiber assembly, filtration product assembly or sub-assemblies. Determines and/or follows methods and sequence of operations in performing fiber bundling, filter potting, filter welding, fitting on assembly units and packaging. The employee also works as a team member in whatever capacity and job function is required to deliver a quality product to our customer in a timely fashion. Performs manual assembly of complex fiber, membrane, and polycarbonate components, etc.

Let’s talk about the team and you: Operates and monitors equipment/process relevant to LSR moulding by following the methods and sequence of operations as defined by verbal instructions, Visual Aids, Quality Forms and/or Routers. Let’s talk about Responsibilities: Performs to individual goals established during MyDay meetings. Operate and monitor production equipment/process – relevant to LSR. Assures product meets or exceeds company and customer expectations of quality and workmanship. Accurately reports production data. Other tasks and responsibilities as assigned. Let’s talk about the team and you: Operates and monitors equipment/process relevant to LSR moulding by following the methods and sequence of operations as defined by verbal instructions, Visual Aids, Quality Forms and/or Routers. Let’s talk about Responsibilities: Performs to individual goals established during MyDay meetings. Operate and monitor production equipment/process – relevant to LSR. Assures product meets or exceeds company and customer expectations of quality and workmanship. Accurately reports production data. Other tasks and responsibilities as assigned.

Responsible for achieving a state of high quality performance at our Supplier partners and pursuing continuous quality improvement through the application of Quality Engineering practices on Philips products/parts/services procured from suppliers throughout the product lifecycle including sustaining change management. Responsibilities: Additions/changes/deletion to Approved Supplier List. Supplier Quality Agreement negotiation. Analysis of defects for determining if supplier caused and then notified. Supplier Quality Notifications and Supplier Corrective Action Requests (SCARs). Drive APQP Plan development, execution, monitoring and control as part of Sustaining Changes. etc.

The incumbent will be a part of the manufacturing organization and provide hands-on execution of tasks related to the GMP manufacture of biopharmaceuticals working in Clinical and/or Commercial fill-finish. Essential Functions: Operate in clean room environment. Assist or perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.) in support of manufacturing intermediate, bulk or final drug product of acceptable quality to meet FDA regulatory quality requirements. Ensure compliance with established internal control procedure. etc.

We are currently seeking a reliable and ambitious team player to join our Laboratory. Our Scientists play a critical role in antibody development and supporting various teams across our organization. Important aspects of this role include excellent organizational, multi-tasking and communication skills, along with the ability to efficiently thrive in a highly interactive and goal-oriented team environment. Job Duties and Responsibilities: Performing laboratory experiments independently or with other team members as instructed. This includes, but not restricted to, buffer preparation, immunoassays creation and manufacture, material processing, column production, affinity chromatography, inventory management and product handling. Maintain laboratory space, equipment and inventory in an appropriate and professional manner. Excellent attention to detail, proactive planning and ability to organize and carry out tasks with quality in a timely fashion. etc.

As part of the pipeline engineering team, you will be responsible for maintaining, improving, and adding to our catalog of production bioinformatics pipelines across an expanding set of modern assays. You will be responsible for scaling our pipelines as we work toward our goal of providing low-cost genetic answers to billions of people. You will work and learn among an extraordinary set of peers: bioinformaticians, molecular biologists, and software engineers. Your work will directly improve the quality of our product and positively impact each tested patient.

As part of our Assay Tools team, you will help ensure that we can grow the breadth and scale of genetic tests on our menu. You will apply your knowledge of computer science, statistics, and NGS to analyze, improve, and develop an expanding set of modern assays. You will work and learn among an extraordinary set of peers: bioinformaticians, molecular biologists, and software engineers. Your work will directly impact early development work focused on improving the quality and capability of our products.

Job duties include: Provide routine analyses in a chemistry or microbiology environment by following standard practices. Perform analytical methods as assigned for testing on raw materials, samples, stability, production intermediates, and/or human cells. Support internal development and/or manufacturing operations. Make detailed observations and review, document, and communicate test results. Conduct routine chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods.

The ideal candidate has a strong background in LC/MS products and a strong technical understanding of the hardware and technology. This role with play a major factor in the development of technology critical to supporting Thermo Fisher Scientific’s position as the leader in mass spectrometry in our San Jose, CA facility. Duties include; Perform detailed root-cause-analysis and work with cross-functional teams on improvements or preventative actions, along with various miscellaneous responsibilities. Perform a failure analysis of LCMS products and parts for medical device regulatory requirements.Work with R & D to ensure new products meet product design criteria for serviceability and develop hardware validation criteria.

Major responsibilities include: Performs routine testing and analysis of components and finished kits according to established Quality Control procedures using different instrument platforms. Documents test results, complete batch records, document problems and other relevant information under cGMPs. Performs initial troubleshooting of issues which arise during routine analysis, perform out of specification (OOS investigations) and if needed, initiate non-conformance (NCAR) reports. Performs initial troubleshooting of issues which arise during routine analysis under the direction of the Supervisor and Technical Operations.

Under general supervision, provide hands on support to local end-users, to restore service and / or identify and correct core problem. Responsibilities include: Recreate user problems to resolve operating difficulties and recommend system modifications to reduce user problems. Escalate more complex problems to appropriate level of management and provide information on problems that are severe in nature or that are exceeding target dates. Adhere to established IT policies, procedures and standards and ensure conformance with information systems, goals and procedures. Provide creative, effective solutions and recommend procedures and resources to enhance efficiency, productivity, and end user satisfaction. etc.

Under the supervision of Manager medical lab, this role will be Perform gross trimming of tissues and organs systems, processing, paraffin embedding, and sectioning for pathological analysis in our pathology laboratory. According to policies and procedures, perform routine and non-routine activities involved in the preparation of slides, for microscopic evaluation by pathologist(s). Secure the slice sample on a slide and use specialized dyes to stain it, bringing out cellular structures and allowing pathologists, or research scientists to identify abnormal cells and monitor cell function.

This role will primarily focus on outbound initiatives including research and evaluation of various health care systems, identifying key medical and administrative contacts, competitive intelligence gathering, and appointment setting. A successful Sales Associate will enjoy making outbound calls to educate medical professionals about iRhythm products and services.

Responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment; maintaining areas in high state of inspection preparedness, and utilizing business systems for inventory and process management. Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:

Catalent has an entry level Associate, cGMP Manufacturing position available. As an Associate, cGMP Manufacturing (Good Manufacturing Practices) you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document cGMP Biomanufacturing activities. Shift position is Wednesday to Saturday (4/10) from 7:00 a.m. to 5:00 p.m. CST. Operates cGMP Biomanufacturing equipment, including pH/conductivity, meters, mix tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH).

As an Associate, Biomanufacturing you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position offering enticing compensation incentives. Work hours are Wednesday to Saturday (4/10). Operates cGMP Biomanufacturing equipment, including pH/conductivity, meters, mix tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH). Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) revisions, deviation investigations and change control/protocol execution, by established due dates. As an Associate, Biomanufacturing you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position offering enticing compensation incentives. Work hours are Wednesday to Saturday (4/10). Operates cGMP Biomanufacturing equipment, including pH/conductivity, meters, mix tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH). Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) revisions, deviation investigations and change control/protocol execution, by established due dates. As an Associate, Biomanufacturing you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position offering enticing compensation incentives. Work hours are Wednesday to Saturday (4/10). Operates cGMP Biomanufacturing equipment, including pH/conductivity, meters, mix tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH). Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) revisions, deviation investigations and change control/protocol execution, by established due dates.

The Solutions Prep, Associate I will perform aseptic techniques within in a clean room environment. Execute and properly document cGMP Biomanufacturing activities. The Solutions Prep, Associate I will operate cGMP Biomanufacturing equipment, including pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and analytical equipment as applicable. The position is expected to follow detailed instructions and established procedures with frequent supervision. Shift position is Sunday - Wednesday (4/10) from 7:00 a.m. to 5:30 p.m. CST. The Solutions Prep, Associate I will perform aseptic techniques within in a clean room environment. Execute and properly document cGMP Biomanufacturing activities. The Solutions Prep, Associate I will operate cGMP Biomanufacturing equipment, including pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and analytical equipment as applicable. The position is expected to follow detailed instructions and established procedures with frequent supervision. Shift position is Sunday - Wednesday (4/10) from 7:00 a.m. to 5:30 p.m. CST. The Solutions Prep, Associate I will perform aseptic techniques within in a clean room environment. Execute and properly document cGMP Biomanufacturing activities. The Solutions Prep, Associate I will operate cGMP Biomanufacturing equipment, including pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and analytical equipment as applicable. The position is expected to follow detailed instructions and established procedures with frequent supervision. Shift position is Sunday - Wednesday (4/10) from 7:00 a.m. to 5:30 p.m. CST.

We are looking for a someone to join a fast-paced, collaborative, and multidisciplinary team to provide QC analysis of raw material, in-process and drug substance testing in support of our GMP operations. The successful candidate will have some experience in analytical chemistry. Experience with chromatography and ELISA techniques is a plus. The ideal candidate has a high attention to detail, is organized in their work and works well independently and in teams. Perform QC analytical testing in support of the GMP manufacturing schedule and drug substance release

This is a position in the Downstream Process Development group involving the planning and execution of purification pilot/scale up and lab-scale confirmation runs for biological therapeutics using chromatography, precipitation, and filtration methods. Duties include: Use of AKTA chromatography systems with Unicorn 7 software. Use of pumps for normal and tangential flow filtration operations. Use of pH and conductivity meters. Assist in the evaluation, development and implementation of new downstream. technologies leading to process improvements and efficiency of operation. etc.

We are seeking an In-Process Support Associate with strong protein chemistry background to perform cGMP in-process analytical support. These services include in-process and release testing for drug substances manufactured internally. Responsibilities include: Execute activities according to cGMP regulations and company SOPs. Provide STAT assay coverage including 2nd shift and weekends as required by the manufacturing schedule. Assays include A280 and RP titer. Log samples or verify sample log in outside of standard business hours. etc.

The Analyst I is responsible for preparation of reagents and solutions, as well as sample processing under required regulatory documentation. May also analyze data, interpret results or contribute to troubleshooting activities. Conducts sample inventory and carries out lab support duties as assigned, such as inventory of chemicals, washing glassware, waste disposal and/or general cleanup.

The individual will support buffer/media production in process development and pilot scale clinical manufacturing for products within the Kiniksa pipeline. In addition, the individual will support upstream/downstream operations in the manufacturing and process development department. This individual will also periodically support other disciplines including shipping, receiving and purchasing. It is preferred, but not required, that the candidate have experience with disposable technologies and solution preparation. The candidate must be highly motivated, eager to learn, science driven, and results oriented in a team environment. 

The successful applicant will use their cell and molecular biology understanding to support the development of autologous T cell transfer therapies. Responsibilities include: Perform supervisor-guided cell and molecular biology experiments in the lab. Contribute to the development and characterization of genetically engineered cancer cell lines, and primary immune cells. Support process development efforts for KSQ’s autologous T cell transfer therapy programs. Document, and communicate experimental design and data

The QC Data Review Specialist will be responsible for GMP review and comment on laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP standards

Operators are responsible for operating special purpose machines or industrial equipment to specifications on production basis in typical oral solid dose pharmaceutical manufacturing. Processes include dispensing and weighing of materials, using automatic and semi-automatic equipment for tablet manufacturing, combining materials to make blends and solutions, and packaging of finished product.

Responsibilities include: Performs all paperwork, technical, and non-technical procedures required to process and submit specimens. Assigns specific computer generated identification numbers, checks for accuracy, and records all items processed. Forwards accessioned specimens to designated laboratory location(s); and locating and correcting any discrepancies. Learns and keeps familiar with lab procedures and location of stored specimens.

Job Duties/Responsibilities: Prepare laboratory specimens for analysis and testing. Unpack and route specimens to their respective staging areas. Accurately Identify and label specimens. Pack and ship specimens to proper testing facilities. Meet department activity and production goals.

Responsibilities include but are not limited to: Routine work in a BSC. Working knowledge and use of micropipettes. Exposure to HPLC a plus. Exposure to IEF. Familiar with SDS page. Etc.

The objective of this position is to perform operations within the Finishing Operations Team to support the manufacture of radioactive products in a timely and compliant manner based on business needs. Incumbent ensures that the integrity and quality of the products produced comply with the associated operating procedures to meet all cGMP, regulatory, and safety requirements. This position may require mandatory overtime, as needed, supporting finishing operations on holidays, weekends, and/or late and early production shifts.

LATITUDE is seeking a Research Associate to carry out individual drug formulation development projects for our clients. LATITUDE utilizes its extensive experience and proprietary technologies to solve issues of insolubility, instability, poor absorption and other formulation challenges over a range of dosage forms for both external clients and internal programs. A successful candidate will possess proficiency in a variety of analytical chemistry techniques including HPLC. This is a salaried, full-time position at our San Diego location.

The Regulatory Affairs and Product Support Associate will proactively support, along with other members of the organization, projects and regulatory submissions for Lifecore customers and their products. They will assist with or lead preparation and maintenance of required regulatory submissions, such as Drug Master Files (DMF), Device Master Files (MAF), design dossiers, change notifications, technical files, etc.; assist with maintenance of Master File database; provide regulatory support to Lifecore customers as necessary; assist or lead complaint handling and MDR/vigilance activities; review and approve change orders and CATSweb actions; review internal change requests to ensure regulatory compliance and good quality assurance practices; assist in compiling, formatting and maintaining documentation for domestic and international product registrations, including making copies and filing; participate in FDA, ISO and Client Audits.

LifeMine is seeking a motivated Research Associate to be an integral member of the Biochemistry team responsible for discovering and developing fungal derived drugs to targets of exceptional therapeutic value. Responsibilities include: Perform enzymatic and protein-protein interaction assays for multiple targets. Execute routine screening assays. Present results at group and/or project meetings. Maintain and track an inventory of biochemical reagents.

The Corporate Development Associate reports to the Senior Director, Corporate Development and Investor Relations and supports all aspects of Ligand’s corporate development (M&A) and general strategy functions with significant exposure to senior corporate leadership. Responsibilities include: mergers & acquisitions (Perform financial valuation and other qualitative analysis on target acquisition candidates, Assist and creation of presentation materials for senior management and Board of Directors review, Monitor market conditions, evaluate companies and/or assets and maintain potential deal list, etc.)

As the primary “storyteller” for your assigned brands, the copywriter partners with senior writers as well as creative leaders to properly understand, articulate and develop copy. Working in a wide variety of mediums, including but not limited to print, collateral, video, digital, etc., you will ensure our content is consistent with the established strategy, brand guidelines, and industry standards. You’ll: Participating in the creation of the brand narrative, from the ground-up. Presenting creative to clients and core constituents. Engaging in productive dialogue as it pertains to brand strategy, narrative arch, and copy to ensure alignment; real-time as necessary with both internal and client teams. Participate in all concepting sessions; taking a standard creative brief to create a varied and deep set of creative entry points. etc.

We form teams of Medical Writers across varying levels of experience to deliver a range of medical services, including researching, developing, and writing content. You will write medical content for our clients who are developing groundbreaking medicines and treatments. Join us to make a difference in making medicines accessible and affordable. Are you an experienced writer in the medical or pharmaceutical communications industry? Do you get excited working with a respected team that ensures the highest writing quality in the work crafted for top pharma clients? If so, this is where you come in. What Your Day-To-Day Will Look Like: Writing high-quality, medically accurate print or digital documents. Acting as a subject matter authority on the supported therapeutic areas. Procuring, organizing, and handling reference materials from a various sources including peer-reviewed scientific journals, government and medical society publications, and reputable websites. etc.

We are excited to invite motivated Research Scientists to consider a career with us. You will provide evidence based-research to life sciences and healthcare companies to shape strategy and inform key healthcare decisions. Successful candidates will have excellent problem solving and analytical skills; a commitment to teamwork and collaboration; an ability to communicate complex concepts to non-technical audiences; and a willingness to deliver high quality results under tight deadlines. What you can expect day-to-day: Using statistical methods and data visualizations to analyze real-world healthcare data. Creating slide decks, reports, and manuscripts that summarize the results of quantitative analyses. Helping develop simulation models for disease burden, comparative effectiveness, or cost-effectiveness studies. Collaborating across a broad portfolio of sophisticated health economic and health policy research projects. etc.

RESPONSIBILITIES: Build eCRFs, including dynamics and matrices in Medidata RAVE. Quality check database structures in accordance with the annotated eCRF. Write and edit check programming in Metidata RAVE. Custom function programming preferred. Perform other database related duties as assigned.

This position is for the production of a Bio-Techne product line. Duties include; Aseptic technique for the manufacture of sterile buffers. Extraction, centrifugation and dialysis of product from various materials. Sterile fill and finish in a clean room environment. Labeling and Inventory control of products. Daily and weekly maintenance of the clean room environment. Future GMP production and additional duties as assigned. Key Responsibilities: Aseptic technique, Dialysis, Buffer preparation, GMP Production. etc.

B-MoGen Biotechnologies is currently seeking to fill the role of a Research Associate (Cellular Therapies) to expand our genome engineering team. This position would focus on completing customer projects, who are interested in transitioning to clinical therapies and or using cells for research and development. Applicants should have a solid understanding of, molecular and cellular biology and will have an emphasis on human pluripotent stem cells. Key Responsibilities: Participate in unique fee-for-service projects for the development, optimization, and manufacture of genetically modified cell lines, primary cells, mouse embryonic stem cells, and human pluripotent stem cells. Create and run flow cytometry panels. etc.

This is a great opportunity to get started with a quickly growing biotech company in Minneapolis! The responsibilities of this position are to answer sales and customer inquiries for availability and order status, pricing, and other order-related questions. ESSENTIAL FUNCTIONS: Enter emailed orders into ERP System. Primary point-of-contact to customer questions related to their order. Ensure customer’s needs and expectations regarding their order are met. Follow through with requests to completion or escalate to Customer Care Specialist when appropriate. etc.

We are seeking Validation Engineers with experience qualifying autoclaves. Responsibilities: Knowledgeable and experienced in performing Autoclave validations and mapping. Writing and execution of validation Protocols IQ, OQ, and PQs for Autoclave. Writing and execution of Validation Protocols for Part Washers IQ, OQ and PQs. Calibration of Thermocouples for Temperature Mapping Studies. Calculation and interpretation of data for Equipment Validation Studies. Develop, Review and modify Standard Operating Procedures (SOPs). etc.

We are looking for an Entry-Level Computer System Validation Engineer to support our client in Irvine, CA. This role would work alongside an amazingly talented PSC Team, and works under the leadership of one of the best in the industry! Successful candidates will have excellent verbal and written communication skills, an understanding of the IT realm, and a thirst to learn! Responsibilities: Provide CSV authoring, review and approval of validation documents developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards. Initiate/update GxP and Risk Assessments on system. etc.

We are seeking a highly motivated engineer to join the Pharmaceutical Development group supporting process development for respiratory drug products. Responsibilities: Support development and optimization of engineered particle inhaled dosage forms. Specific methods may include bench and pilot-scale spray drying. Support development of new technologies. Perform physicochemical property and aerosol performance characterization of solid-based inhalation dosage forms. Support batch manufacture for development, pre-clinical and clinical studies. etc. We are seeking a highly motivated engineer to join the Pharmaceutical Development group supporting process development for respiratory drug products. Responsibilities: Support development and optimization of engineered particle inhaled dosage forms. Specific methods may include bench and pilot-scale spray drying. Support development of new technologies. Perform physicochemical property and aerosol performance characterization of solid-based inhalation dosage forms. Support batch manufacture for development, pre-clinical and clinical studies. etc.

The Pharmaceutical Technician will efficiently, effectively, and safely clean, set-up, and operate machinery in the manufacturing and/or packaging area while adhering to applicable cGMPs, SOPs, FDA, and DEA guidelines. Primary Responsibilities: Follow Master Batch Records for the manufacturing and packaging of controlled, oral solid dose (OSD) and other dosage forms when required. Prepare raw materials, blends, and bulk accountability throughout manufacturing processes. Performs weight checks for incoming and dispensed materials ensuring compliance with established procedures. Operates scales including set-up, verification, leveling and challenging. Identify, report, and resolve quality issues. Safely and in compliance with batch records and SOPs, set up, operate, and clean manufacturing and/or packaging equipment (oral solid dose manufacturing and packaging may include rotor sieves, granulators, blenders, coaters, encapsulators, compression machines, etc.). etc.

Under general supervision, perform various manufacturing related activities for a GMP compliant Fill/Finish operation applying standard practices, techniques and procedures. Able to assist in the preparation of reports, records, etc., for assigned tasks. PRINCIPAL DUTIES: Familiar with related GMP procedures and requirements, as directly related to the position. Ensure that appropriate procedures and processes are utilized without unauthorized modifications. Ability to set-up, maintain and perform various manufacturing related activities as required for a GMP compliant Fill/Finish operation.

Whether their focus is on small molecules, proteins, antibodies, vaccines or oligonucleotides, QPS provides our clients with a full range of services to support the entire spectrum from early discovery, to IND-enabling ADME, to clinical studies. An Associate Scientist in our DMPK department will be a fully-supervised trainee, responsible for formulations, and sample processing and analysis to support preclinical drug discovery and development. Essential Functions: Assist with quantitative and qualitative bio-analytical studies by conducting sample preparation with various analytical chemistry methodologies. Perform routine lab operations, such as sample extraction, preparing reagents, pipette, weigh, monitor, record, label tubes, order and maintain inventory of supplies, and timely disposal of study samples, in a neat/clean manner. etc.

Whether their focus is on small molecules, proteins, antibodies, vaccines or oligonucleotides, QPS provides our clients with a full range of bioanalytical solutions to support the entire spectrum from early discovery, to IND-enabling ADME, to clinical studies. An Associate Scientist in our Bioanalytical department will be a fully-supervised trainee, responsible for sample preparation by various extraction methods; analysis of drug and metabolites in biological samples to support preclinical and clinical drug development programs under GLP regulations; and recording study results and observations. If you have a Bachelor’s degree in Chemistry, Analytical Chemistry, Biochemistry, Pharmacology, or other related disciplines and want to be part of an organization and industry that is making a difference, we would like to hear from you.

The Data Management Associate is an entry level position within the functions of the Data Management Department, including the maintenance of trial related source documents, as well as the timely reporting of clinical data to clients and/or regulatory authorities. The Data Management Associate must possess strong time management skills in order to effectively compile and manage source documents, perform data entry, QC source documents and transcribed data, participate in client interaction and requests, and perform short term or long term projects as required by the department manager and/or department supervisor within contractual timelines. etc.

The Immunotherapy Technician I position will work under the close supervision of the Immunotherapy supervisor to carry out the following departmental responsibilities: aseptically filling immunotherapy vials and preparing all products for final packaging and shipment. This position will require the ability to multitask as well as follow standard operating procedures at all times. Performs aseptic hand filling operations, Prepares raw materials and filling operation set-up, Inventories all of the department raw materials and products, etc.

Assist in conduct of clinical studies. Provides licensed nursing coverage for studies and performs procedures as allowed by training and delegation. Duties include: Assist in the conduct of clinical studies while providing licensed coverage. Performs all job responsibilities in accordance with standards of Good Clinical Practice (GCP), clinic standard operating procedures (SOP’s), and OSHA guidelines. Perform tasks such as EKG’s, vital signs, phlebotomy, insertion and maintenance of IV catheters. Communicates in a timely manner with physicians regarding patient safety concerns, adverse events, protocol deviations, and any study conduct issues.

Responsible for the manufacture of GMP oligonucleotides; the continuous improvement of these existing oligo processes; and the development/transfer of new oligo processes. Provides oligo process support to Operations group through instrument/oligo process troubleshooting and completion of NCR investigations. Responsible for research, development and production manufacturing activities associated with oligos.Essential Duties and Responsibilities The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

The Quality Control Analyst ensures all Quality Control (QC) activities at Hovione LLC are carried out in compliance with Corporate Operating Procedures (COP), Standard Operating Procedures (SOP), Internal Operating Procedures (IOP), and Federal Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Occupational Safety and Health Administration (OSHA), and Environmental Protection Agency (EPA) requirements. Responsibilities include: Perform analytical testing (i.e. raw materials, intermediates, API, stability, cleaning, method validation and cleaning) in a timely manner to meet deadlines; Execute qualification tests contained in protocols for equipment qualification; Perform instrument calibrations on Balances, High Pressure Liquid Chromatography (HPLC) and Gas Chromatography (GC); Carries out routine tasks, routine housekeeping related to the laboratory, and maintenance of analytical equipment.

The Process Engineer will ensure that the use of the best process engineering knowledge will be applied in scaling up chemical and spray drying projects to maximize customer satisfaction and Hovione’s interests and in compliance with all Federal, State, Local and internal policies. Main responsibilities include; Plan and design manufacturing processes based on chemical procedures to run safely and effectively in a pilot plant/kilo lab in accordance with the best known practices ensuring cGMP compliance. Contributes to the Process Hazard Analysis (PHA) of all processes under his/her responsibility and assures that all identified hazards are addressed prior to performing any activities within operations. Prepares Mass balance sheet, instructions for unit operations, production batch records, Bill of Materials and other GMP related documentation for all processes run in operations. etc.

The successful candidate will have responsibilities for reviewing and updating lab quality control processes, reviewing and analyzing results of tests to improve product quality level and maintaining product inventory. Tasks will include preparing product for internal and external customers and operation, maintenance and calibration of laboratory equipment. They will utilize standard procedures to formulate, test, fill and assemble product. Operates and maintains automated laboratory equipment, such as pipettors, scales, incubators, PCR/qPCR instruments and nucleic acid sequencers. Assembles reagents, kit orders, and other products for shipment to customers in accordance with standard protocols. Formulate reagents and solutions utilizing Standard Operating Procedures (SOP’s) and approved Work Instructions (WI’s). etc.

A Equipment Operator I is responsible for the safe and efficient operation of simple automated assembly machines. This individual will ensure the continued operation of assembly machines through interpretation of and appropriate response to machine faults and through infrequent alignment of stations and fixtures. This individual will perform simple, repetitive tasks associated with machine operation and will operate machines that require a low level of attentiveness. The operator is also responsible for ensuring that medical devices are assembled with the highest quality possible.

Technician will assist Manufacturing team in production of medical devices. Successful candidate will work within a high-energy, small, focused team environment and maintain a strong sense of shared responsibility and shared reward to make work fun and interesting. Work with Medical Device Production team in a moderate-volume commercial laboratory to fabricate polymeric films, perform and assist in daily laboratory tasks and work flow, maintain and edit standard operating procedures and work instructions, record data, write reports and communicate results. Ensure quality control of materials and end products of the company in a consistent manner.

As a Laboratory Technician, you will be responsible for performing routine and preventative maintenance on all Automated Instrumentation in the R&D labs. You will also maintain and order department supplies and raw materials for R&D labs including stocking supplies and performing cycle counts. Repairing and replacing parts as necessary on all automated instrumentation in R&D labs. Assuring all personnel are in compliance with all departmental laboratory procedures, OSHA safety regulations and other safety related procedures.

Research Associate plays a pivotal role in our R & D teamwork on novel projects involving drug-device combinations for treating chronic diseases with the potential to dramatically impact patient outcomes. Responsibilities include: Independently carry out technical aspects of research projects including formulation work, sample preparation, conducting experiments, recording and managing data, and communicating results to supervisors and research team. Conduct bioanalytical assays and analyze data for the quantification of analytes. Record and manage data from complex experiments including preliminary statistical analysis

The Clinical Specialist must provide the healthcare professional with the most current information pertaining to Indivior products and their approved indications in a manner which will ensure the appropriate use of these products and achieve the business potential of the territory. Responsibilities include: Invest the time and the effort to achieve the established goals for the territory such as sales, market share, doctor calls, appropriate program planning, etc. Plan and organize daily sales call activities to optimize the use of time and maximize the achievement of sales objectives.

Assists with preparation of autoimmune diagnostic Immunofluorescence Assay (IFA) slide, control and conjugate products in accordance with established procedures. Major duties include preparation activities for IFA controls and conjugates and the growth of cloned antigens in insect cells. Maintains detailed Device History Records, laboratory notebooks and/or any associated documentation for all manufacturing and evaluation activities in accordance with current Quality Systems Regulations (QSRs). Tests IFA slide products for acceptable titer and pattern reactivity according to written Manufacturing Documents. Assists with the maintenance and growth of insect cells and the harvesting of various cloned antigens from these cells according to established procedures.

As a member of the Technical Support Team, provides product and technical support to customers via phone and email on all Inova products. Responsible for assessing customers’ needs and delivering exceptional customer service to provide remote support, basic troubleshooting, and issue resolution for Inova customers. Responds to customer product inquires on a broad range of technical questions regarding instrument and assay performance, instrument capabilities, quality control, and other product concerns. Interpersonal skills and technical product knowledge, judgement and decision making expertise are critical to responding to daily customer-centric activities.

The primary purpose of this position is to perform work which involves conventional engineering practice. Ensures Integer's internal and external customer expectations are met or exceeded. Accountabilities & Responsibilities: Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.

The primary purpose of this position is to develop competency in and performance basic assembly and/or inspection operations at Integer. The incumbent is expected to follow written procedures to meet production and quality requirements. Sets up equipment needed for assembly/inspection as per Manufacturing Process Instructions (MPI's) and Quality Work Instructions (QWI's). Understands own tasks and how they relate to others on their team. Works under close Supervision where duties are clearly defined. Will follow Standard Work where applicable. Assembles component parts as per print. Utilizes both manual and automatic machine operation.

Primary Purpose: To develop competency in and perform basic assembly and/or inspection operations at Integer. The incumbent is expected to follow written procedures to meet production and quality requirements. Responsibilities include: Set up equipment needed for assembly/inspection as per Manufacturing Process Instructions (MPI's) and Quality Work Instructions (QWI's). Assembles component parts as per print. Utilizes both manual and automatic machine operation. Visually and/or dimensionally inspects parts and/or completed assemblies for conformance to specifications. Identifies and escalates quality non-conformances.

The individual will be responsible for all material handling on 1st and 2nd shifts as well as aspects of receiving, shipping, inventory control and inventory movement. Other responsibilities include processing returned materials. Transact receipts, shipments, movements and work orders in a MRP system. Use department databases to track and manage Finished Goods and Raw Material Inventories. Effectively follow SOPs, policies and ISO/QSR requirements. etc.

We are seeking a Technology Sales Associate to join our Philadelphia-based sales, marketing and business development team. Responsibilities include: Lead generation and data entry into customer relationship management (CRM) system. Conduct marketing and sales efforts targeting large and small antibody biotech customers. Prepare sales reports on product performance.

Job duties as a research associate include: Assemble study designs, perform laboratory experiments, organize data, and analyze results under minimal supervision. Set up and perform HPLC, as well as other assays, to characterize protein and peptide molecules. Analyzes, records, and reports the results and conclusions for laboratory experiments. Summarizes and interprets data. The candidate should also be open to learn new laboratory techniques and work under the guidance of experienced researchers.

Primary Function of Position: Install and support the Intuitive Surgical products and ensure service agreements and warranty obligations are fulfilled. Exceed customer expectations and maintain customer satisfaction to the highest possible level. Responsibilities includes: Pre site verifications to prepare site for system installation. Assist in coordination of system delivery (e.g. confirming site readiness) Troubleshoot and repair Intuitive Surgical products and associated equipment failures as required. etc.

The open associate scientist position is one that will support all in vivo, small animal medical imaging studies. These studies include nuclear medicine (PET/SPECT), computed tomography (CT), and magnetic resonance imaging (MRI). The Associate Scientist will maintain the animal and imaging facility, provide study support in mouse and rat disease models ranging from basic injections to surgical procedures, and assist in image acquisition procedures. This position will be an immersive cross-functional opportunity where an ideal candidate will identify areas in which to excel and focus a career in research. A qualified applicant is enthusiastic about biomedical research, able and willing to rapidly learn new skills and begin applying them immediately.

Precision BioSciences is seeking a detail oriented molecular biologist with recent laboratory experience for a Research Assistant position. The position will be responsible for routine cloning, DNA preparation and manipulation of bacterial and mammalian cells. The candidate must be a fast learner, meticulous and have a track record of successful bench work. The position is working closely with a large, friendly team in a fast-paced, collaborative environment. As a member of the Core Technology team, the Research Assistant will be responsible for: cloning a variety of constructs into plasmid DNA, plasmid DNA purification, genomic DNA purification, PCR, generation of electrocompotent bacteria. etc.

The Associate Research Economist is responsible for collaborating across a broad portfolio of sophisticated health economic and health policy research projects as a member of a project team. The Associate Research Economist will have a familiarity with the application of research methods (e.g. literature review, modeling, observational research, statistical programming) and the ability to utilize specific discipline knowledge gained through academic and/or work experience (e.g. economics, etc.). This position will perform a wide range of activities including: literature review; analysis; preparing reports, slide decks and meeting notes; quality assurance/review; and other activities, under the direction and supervision of a project leader. etc.

As an Associate Research Scientist, you will responsible for collaborating across a broad portfolio of sophisticated health economic and health policy research projects as a member of a project team. You will have a basic familiarity with the application of research methods (e.g. literature review, modeling, observational research, statistical programming) and will execute a wide range of activities including: project management; literature review; analysis; preparing reports, slide decks and meeting notes; quality assurance/review; and other activities, under the direction and supervision of a project leader. etc.

As an Associate Research Statistician you will develop and implement advanced research across a broad portfolio of evidence synthesis and decision modeling research projects. Associate Research Statisticians collaborate with project teams to execute analytical work, as well as contribute to the development of the department as a whole. Essential duties include but are not limited to: conducting meta-analyses and network meta-analyses, conduct statistical analyses to support projects, draft interim and final project deliverables for clients. etc.

As the primary “storyteller” for your assigned brands, the copywriter partners with senior writers as well as creative leaders to properly understand, articulate and develop copy. Working in a wide variety of mediums, including but not limited to print, collateral, video, digital, etc., you will ensure our content is consistent with the established strategy, brand guidelines, and industry standards. You’ll: participate in the creation of the brand narrative, from the ground-up, present creative to clients and core constituents, engage in productive dialogue as it pertains to brand strategy, narrative arch, and copy to ensure alignment. etc.

What you'll do... Cash applications: timely and accurate application of daily payments received against outstanding invoices in the General Ledger, accurately report Member AR aging report and Member cash received by Month, perform other duties and special projects as assigned. Payroll: process semi-monthly payroll for all employees (hourly and salaried), provide routine monthly reports requested from payroll. etc.

Assist and support the Environmental, Health and Safety (EH&S) department by performing tasks that ensure a safe workplace and sustain Promega’s compliance with Local, State, and Federal environmental, health, and safety regulations. ESSENTIAL DUTIES: 1. Collect chemical, biological, and radiological waste from satellite accumulation areas in all facilities. 2. Properly identify, segregate, process, label and store chemical, biological, and radiological waste according to standard operating procedures and applicable regulations. 3. Schedule, organize and oversee the packaging, labeling, shipment and disposal of chemical, biological, and radiological waste at all facilities. Complete, track and file hazardous and non-hazardous waste manifests and other shipping papers for chemical, biological, and radioactive waste shipments from all facilities. etc.

Physical Sciences Inc., located just north of Boston in Andover, is looking for a chemical scientist to conduct research, development, test and evaluation (RDT&E) of innovative energetic materials for propulsion and munitions systems. Emphasis is placed on laboratory scale and pilot scale processing of ingredients and formulations for fuels, oxidizers, propellants, and explosive compositions. We are seeking an individual with a strong background in wet chemistry and analytical instrumentation to join a multi-disciplinary team of engineers and scientists. This individual will play a key role in growing a diverse portfolio of technologies funded by the DoD and NASA. etc.

The Research Associate 1, Medicinal Chemistry will be a critical member of the research team reporting directly to one of our Scientists. This is an exceptional opportunity to gain experience in a successful biopharmaceutical company and bring drugs from ideas to the clinic. Responsibilities include, but are not limited to: Multi-step synthesis, purification and characterization of small molecules for evaluation as potential drug candidates, maintain various lab equipment, maintain current knowledge of synthetic methodology through literature readings, present progress at chemistry group and project team meetings. etc.

PMI Biopharma Solutions is looking for an Analytical Development team member that is passionate and driven regarding his/her work. PMI Biopharma Solutions desires a team member eager to work in an environment where people are motivated to do their best for the company and its clients. Reporting to the Microbiology Supervisor, the Microbiologist I will be responsible for performing environmental monitoring sampling of ISO class environments and assisting with preparation, characterization, and identification of environmental isolates. He/she will perform raw material and drug product method development and cGMP testing. etc.

Poseida Therapeutics, Inc. is seeking an outstanding candidate to join our Cell Therapy Development group at our La Jolla, San Diego, CA location. The Development Associate will be a key member of a dynamic team that develops and implements characterization strategies to support and enable process and clinical development of gene-engineered cell products. This is a lab-based position that will involve hands-on development of clinical manufacturing processes for selecting, gene-modifying and growing T cell subsets. This position will interface with our Research and Development team as well as with outside Contract Manufacturing Organizations. etc.

As an Associate Scientist, you will use state-of-the-art technologies to perform high-quality sample testing for key pharmaceutical clients across the industry. Your sample preparation and sample analysis serves as an integral piece in helping PPD accomplish our goal of helping bring life-changing therapies to market. In this position you will perform a variety of validated or experimental analytical procedures such as ELISA. You love science and have keen observation skills. You are a self-directed learner with excellent attention to detail. You have an inherent scientific curiosity and enjoy working with instrumentation. etc.

We are seeking a passionate, highly organized, sharp individual seeking to begin a career in Operations in a lab setting. As an Associate Scientist/Lab Ops Tech you will perform a variety of tasks such as arranging supplies and supporting the Immunohistochemistry, Pathology and Histology in the Translational Medicine group. Your role will strictly be laboratory operations, and not include any bench work. You, as the Associate Scientist will assist scientists through tasks such as shipping and receiving, reagent and supply ordering, inventorying and stocking, lab cleanliness, safety, setting up equipment service & maintenance and record keeping for the labs. etc.

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.

Applies knowledge of technical principles and Edwards systems/procedures to tptimize manufacturing processes. Responsibilities include: Improve manufacturing processes using engineering methods for concinous process improvement. Develop basic experiements and tests to qualify and validate manfactruing process, etc.

Supports all phases of clinical study activities including: TMF review, assist with filing and archiving project documentation in theTMF within a 20 day timeframe. Assist with creating, updating and maintaining project trackers in EPIC. Provides support for document preparation. Attend internal study team meetings, and prepare and distribute study team agendas and minutes. etc.

Multiple positions. Position titles include but are not limited to Plant Engineer, Process Engineer, Project Engineer, Development Engineer, Automation and/or Control Engineer, and are available in manufacturing and development areas supporting: Bulk processing (Animal health products), facilities/utilities engineering, process development.

The successful candidate will be responsible for developing and performing cell-based assays within the Immunology team achieving common team goals. Responsibilities include: Perform ex-vivo and in-vitro cellular assays with an emphasis on flow cytometry and immuno-assays including ELISA and MSD. Analyze and interpret data and generate high-quality summary reports in a timely manner, and present findings in the inter and intra departmental group meetings. Document experimental data and results and maintain a current and accurate electronic notebook (ELN)

We have an opening for a talented Associate Scientist to join the ImmunoOncology platform at EMD Serono, Billerica, MA. The successful candidate will support the discovery of novel cancer immunotherapies. In his/her role, the candidate is expected to develop and conduct cellular immune assays to characterize small molecules or biologics that modulate the tumor immune environment and enhance the anti-tumor immune response.

Execute tasks per cGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing qualification block training program. Actively incorporate the Core Values set out by Emergent BioSolutions while performing day to day activities. Maintain state of facility environmental control including: preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing surfaces and equipment per Standard Operating Procedures. etc.

Under the direction of Process Development management, the Associate Engineer will perform experiments (hands-on) to develop, scale-up, and improve the performance of unit operations. The Assoc. Eng. will apply technical training to assess risks, solve problems, and analyze data sets coming from experiments and present results. This includes: preparation of solutions/media, cell culturing and related processes, tubing assembly and sterilization, development studies, etc.

The Analyst II, QC Microbiology position supports the Quality Control group at Emergent BioSolutions Camden Campus to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the Microbiology, Environmental Monitoring, and Utility testing programs, which includes microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives.  The individual routinely conducts monitoring, testing, and SOP generation and revision.

The QC Analyst I – Microbiology will perform microbiological testing, release of in-process, intermediates and finished products, and testing for validation purposes. This role completes appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms.  Additionally, this role is responsible for assisting with the writing of standard operating procedures (SOPs) and revision of existing documentation.

Under general supervision performs repetitive inspection tasks on assembled products using Standard Work Instructions and Device History Records (DHRs) while maintaining training certifications. Will work from written and/or verbal instructions while maintaining pace with production requirements. Will interact with internal customers to help resolve, inspection and/or components issues. etc.

The Surgical Instrument Repair Excellence (SIRE) Apprenticeship Program is a two to three-year process that is monitored by the Department of Labor (DOL). The first 4 – 6 months of initial training will be based out of the Houston Training Center (HTC). After completion of the training at HTC you will be required to spend the remainder of the introductory 6 months with established field personnel at their home sites. Learn and become proficient in all aspects of handheld stainless steel instrument sharpening, repair and maintenance (Maintain an average score of 80% on all written and technical assessments).

As an Advanced Quality Engineer, you will support the development of one or more products from concept generation through production, having the unique opportunity to realize the entire product lifecycle. Specifically, you will: Partner with marketing and design to understand user needs and translate those into engineering specifications that constitute the basis of the design. Lead the development of a safety risk management strategy including implementation of risk controls. etc.

Maintenance Technicians are responsible for general repairs and maintenance on buildings, structures and equipment. Maintenance Technicians are generally tasked with day-to-day upkeep of facility equipment that provides vital resources for animal breeding. Performs electrical, electronic, mechanical, hydraulic, and pneumatic maintenance and repair of machinery, equipment, and HVAC system. Performs diagnosing malfunctions in machinery and equipment. Performs dismantling, assembling, and installing industrial machinery. etc.

The technologist will perform qualitiative and quantitative tests and examinations using various analyzers and/or manual methods. Assist in peforming established quality assurance procedures (quality control testing, instrument function checks and calibrations). Mainatains appropriate documentation and reports irregularities.

Conduct analytical runs for R&D purposes using a set of analytical techniques such as HPLC, UPLC, GC, including writing related protocols and reports. Develop, evaluate, validate analytical methods for raw materials and finished products. Support the transfer of developed and qualified assays to relevant clients. Provide support, as related to analytical, plant trouble shooting/investigations and product regulatory submission. Provide full analytical development support in accordance with cGMP/GLP practices to product development programs within strict timelines to successfully meet internal and client program milestones. Support the AR&D related activities for filing of new ANDA. Support the generation of pharmaceutical development reports and related documentation.

Duties include: performing routine biopharmaceutical characterization studies including UV/Vis, size exclusion, cation exchange chromatography. Support other methods such as mass spec, or immuno-based assays. Conduct experiments and record/interpretate data.

Carries out routine experiments and procedures in accordance with all applicable regulatory (e.g. DEA, EPA, FDA, FIFRA, OECD, etc.) requirements as defined by protocol, method, and standard operating procedures (SOPs). Assist/run toxicology studies, including preparing test solutions and daily maintenance of test systems. Feed, water, and examine animals for signs of illness, disease, or injury sustained in the laboratory. Performs analysis, first level, and peer review of data for accuracy and completeness.

Responsibilities include: Develop, qualify and validate analytical test methods for drug products, intermediates and excipients. Design and execute analytical development studies. Write protocols and repors. Maintain and write SOPs. etc.

The Risk Analyst will provide appropriate business risk assessments, identify areas of risk of loss, quantify the impact, develop and evaluate policies and provide guidance to the Company’s decision makers. The Risk Analyst is important role within the organization to minimize the impact of operational and financial risk to the enterprise.

Candidates should love laboratory science and should enjoy technology innovation. You will work with a group of creative inventive scientists on developing novel state-of-the-art methods that are the basis for important new products to improve medical outcomes for patients with serious infections. Responsibilities include: developing experimental designs, preforming microbiological/molecular biological experiments, and other lab-related work.

Responsibilities as a research associate include: serving as a key member for testing, analyzing, and developing microfluidic devices. Integrate biochemical reactions in microfluidics. etc.

Responsibilities as a test engineer at Fluke iclude: plan/implement test systes for new product introductions. Support/maintain/improve test systems throughout factory. Advise design engineering of existing production capabilities. etc.

Duties include: develop and implement all quality-related processes and documentation. Direct manufacturing process development to meet quality metrics. Monitor faility performance and associated metrics. Etc.

Reports to manager, QC chemistry technical services. Responsibilities include: Method transfers/method verification/Co-Validations of compendial and non-compendial analytical methods utilized across Fresenius Kabi according to written procedures. Testing of routine and non-routine samples where specialized training is essential. etc.

Responsibilities include: Assist with all aspects of EHS, including applicable OSHA regulations, environmental record keeping, safety audits, and accident investigations. Ensure the Emergency Response Plan remains current with regulatory requirements and site needs, assist with the readiness of FDBT personnel and facilities to respond to emergencies. Conduct environmental and safety audits and inspections; assist EHS Management with reporting to Senior Leadership.

Responsibilities include: Construction of gene libraries and expression vectors. Characterization of gene variants. Primer design. DNA isolation. DNA sequencing. Cloning of genes and genetic pathways. Work with project teams to provide support and assistance to all phases of directed evolution projects, contribute to team presentations and written reports.

Codiak is seeking a qualified associate scientist to join our growing Research organization and contribute to the development of the company’s innovative exosome engineering platform. Responsibilities include: Produce, purify, and characterize engineered exosomes from conditioned cell culture medium; Execute biochemical and cell-based assays to validate target and pathway engagement of therapeutic candidates; Express and purify recombinant proteins, including antibodies, enzymes, and fusion proteins, at the milligram scale to support assay development for ongoing projects;etc.

As a member of the engineering services team, the Electrical Engineer I will solve complex problems and participate in the specification, design, prototyping and testing of a diverse range of tooling, fixtures, design for manufacturability projects, and other customer product design needs. Under the direction of the Electrical Engineering Manager, the engineer in this role will be performing design tasks of a complex technical nature requiring investigation of new technologies, and applying engineering design principles and practices.

The successful candidate will be responsible for developing and executing standard work procedures on a wide range of molecular biology techniques related to Next Generation Sequencing. Execute on and assist in the development of process instructions that ensure accuracy, throughput, and quality. Operate and monitor laboratory automation and instrumentation. Communicate issues and failures as necessary to the appropriate parties. General lab duties, such as restocking supplies and maintaining inventory.

The Design Engineer I will be responsible for design and development of new orthopedic implants and related instrumentation systems and the creation of documentation in support of quality systems and concept to medical device which achieve quality, cost and time to market requirements. Understand the objectives, responsibilities, and mission of the Engineering department and works towards those goals. Develop protocols for design verification and validation (V&V), including outside test and research labs. Complete corresponding test reports. Communicate with customers, sales, marketing and independent entities to gain knowledge of product design requirements.

The primary purpose of the Quality Engineer (Post Market) position at Cook Winston-Salem is complete and review post market quality engineering activities, including complaint investigations, risk assessment, post market feedback, and product quality issues. Responsibilities include: Perform complaint investigations, including technical assessment of returned products. Complete risk assessments using post market data. Assist with the investigation, risk assessment and resolution of product quality and quality system issues. Implement, support and maintain post-production quality activities.

The incumbent will be a shop floor employee in the manufacturing organization. The incumbent will provide (be trained in) the technical skill-sets necessary to manufacture high quality biologicals or sterile injectables safely in a compliant, efficient, and cost effective manner. Responsibilities include; Becomes trained on basic processes and equipment and serves as a hands-on resource in Production. Cleaning, preparing, and sterilizing production equipment. Assembly, set-up, and disassembly of production equipment. Handling biologically and chemically hazardous goods

We are looking for only the most driven Electrical Engineers with solid engineering fundamentals. Responsibilities include: Circuit simulation/modeling, Bench data collection, Scripting & overall test automation, Chipset evaluations (e.g Bluetooth, MCUs, accelerometers…), PCB design & layout, etc.

Responsible for the creation and transfer of manufacturing processes from R&D to Manufacturing and continuous improvement of existing processes. Responsibilties include: Maintains the Pilot Plant laboratory under cGMP conditions. Produces development, pilot and production materials per written instructions. Stocks and maintains the laboratory supplies. Completes laboratory work and associated paperwork by assigned completion dates

Responsible for the manufacture of GMP oligonucleotides; the continuous improvement of these existing oligo processes; and the development/transfer of new oligo processes.  Provides oligo process support to Operations group through instrument/oligo process troubleshooting and completion of NCR investigations.  Responsible for research, development and production manufacturing activities associated with oligos. Independently produces notebook, dev, pilot and production materials per written directions.

The ideal candidate is one who understands complex electro-mechanical systems, and how they interact with software, manufacturing, service, and external vendors, to fulfill product requirements. This position would report to the Director of Research and Development. Designs and directs engineering personnel in fabrication of test control apparatus and equipment, and determines methods, procedures, and conditions for testing the engineered products and associated apparatus. Applied electrical engineering knowledge concerning the research, design and development of new products having state-of-the-art sophistication for X-ray generators, data acquisition, signal processing, power supplies, etc.

The main responsibility of the Manufacturing Sciences technician is to support the manufacturing team as a technical advisor and operator. Manufacturing Sciences technicians adapt processes demonstrated at the R&D scale to final manufacturing scale. Secondary roles include driving/contributing to continual improvement initiatives and providing input to production scheduling

This position will report to the Principal Investigator – Biological Sciences in the Lawrence, KS research facility. Key responsibilities include: Perform primary screening of small molecules utilizing cell-based assays. Primary responsibility will be in the area of screening small molecule kinase inhibitors. Perform routine mammalian cell culture. Together with supervisor, responsible for validating new biochemical or molecular biology-based assays and trouble-shooting when needed to establish reliable screening platforms.

This position will report to the Sr. Manager, Regulatory Affairs and be located in the Waltham, MA office. Responsibilities include: Under supervision, the Regulatory Affairs Associate will work with cross functional colleagues in providing support for clinical and CMC regulatory filings, creation of internal regulatory documents, and assist with ensuring internal compliance with GXP regulations and policies. Define contributions for submissions, communicate to functional contributors and track delivery according to agreed timelines. Identify and compile all materials required in U.S., EU, and other ex-US regulatory submissions, this includes annual reports, DSURs for INDs, CTAs, IND/NDA/MAA applications, etc. as necessary

Key responsibilities include: Rodent dosing, sampling and necropsy; planning and performing of all technical aspects of in vivo experiments; contributing to experimental design and strategy. Cross-functional collaboration to help enable efficient operation of our on-site animal care facility (ACF). Performing laboratory assays according to SOPs, troubleshooting as needed; assay development. Generating data using both standard and novel molecular technologies. Contributing to a team tasked with evaluating novel experimental medicines in preclinical models of disease, and advancing our technology to enable development of the next generation of innovative RNA-based therapeutics.

The technologist assistant assists the technologist with patient care by transporting patients between the facility and scanner; sanitizing and cleaning patient care and staff areas; changing table linens; entering exam and patient information electronically or on paper; and answering the telephone. The technologist assistant demonstrates the knowledge and skills necessary to provide care appropriate to the age of the patients served. The individual demonstrates knowledge of the principles of growth and development over the life span. He/she is able to identify and categorize each patient’s age-specific grouping of needs, such as those for infant, pediatric, adolescent, adult or geriatric patients.

The technologist assistant assists the technologist with patient care by transporting patients between the facility and scanner; sanitizing and cleaning patient care and staff areas; changing table linens; entering exam and patient information electronically or on paper; and answering the telephone. The technologist assistant demonstrates the knowledge and skills necessary to provide care appropriate to the age of the patients served. The individual demonstrates knowledge of the principles of growth and development over the life span. He/she is able to identify and categorize each patient’s age-specific grouping of needs, such as those for infant, pediatric, adolescent, adult or geriatric patients.

Performs basic and routine functions associated with the maintenance or repair of the manufacturing process including machines and equipment. Utilizes fundamental knowledge of a select number of machines, equipment and manufacturing processes to perform duties that may include but are not limited to: performing electronic, electrical or mechanical troubleshooting to determine problems in non-functioning equipment or machinery used in the manufacturing process; dismantling, adjusting, repairing and assembling equipment and machinery according to layout plans, blueprints, operating or repair manuals, rough sketches or drawings; using test and diagnostic equipment to perform checkouts; rebuilding or modifying manufacturing equipment as required. May troubleshoot software as it pertains to test equipment or machinery as needed.

Dragonfly Therapeutics seeks an experienced and motivated Laboratory Operations Coordinator to help supportnovel cancer immunotherapy programs. The candidate must be independent, goal-oriented, flexible, and able to work efficiently in a laboratory environment as well as an office setting. Responsibilities include: Monitor day to day lab operations and support equipment maintenance, stock lab consumables, and collect asset and maintenance data. Provide office operational support to colleagues, partners, and ongoing research collaborators by helping with procurement, researching supply issues, and providing supply options. Create, manage, and participate laboratory and office protocols such as safety procedures, lab emergency response, and communicating general lab rules and company policies.

This individual will also assist in the development and execution of isolation and cryopreservation procedures for various cell types (PBMCs, T cells, CD34+, etc.). Candidate must be experienced with aseptic technique and be versatile to assist in the development and execution of processes for normal donor cellular products derived from different lineages of cells. Candidate must be experienced with aseptic technique and be versatile to assist in the development of processes for autologous or normal donor cellular products derived from different lineages of cells (T cells, HSCs, etc.).

An ideal candidate should have a background in immunology, cancer biology, and a strong interest in genome editing. Responsibilities include: Develop and optimize protocols for gene editing, including: delivery methods, culture conditions, scale up, and multiplexing. Culture primary cells and cell lines. Perform basic molecular biology work such as DNA and RNA extraction and PCR. Develop and perform immune cell activation, cytotoxicity, and other cellular and ELISA-based assays to evaluate gene editing approaches in cell therapeutics in vitro and in vivo. etc

The candidate will play a significant role in the implementation of in vitro studies to characterize and differentiate the biological consequences of our small molecule therapeutics to advance early drug discovery programs. Responsibilities include: Perform cell-based studies to support identification/validation/differentiation of small molecule mechanism of action. Routine implementation of a wide variety of laboratory techniques: mammalian cell culture, cell-based genetic engineering (lentiviral, CRISPR), flow cytometry, etc. Maintain written records of laboratory experiments, data, conclusions and communicate results in a clear/concise manner.

Key responsibilities include: Participates in gathering requirements (user requirements, business process requirements) from business users using appropriate mechanisms and following CSL standards. Responsible for identifying the design of approved changes and updating/creating the required system design documentation (design details, diagrams and charts, functional and configuration specifications) to ensure the visualization of the technical implementation. Contributes to the compilation of validation testing. Responsible for the ongoing operation and maintenance of applications for the assigned IT functional areas. This includes providing 2nd or 3rd level incident support, change management, and maintaining the upkeep of technical records and documentation.

The incumbent will be a shop floor employee in the manufacturing organization. The incumbent will provide (or be trained in) the technical skill-sets necessary to manufacture high quality biologicals safely in a compliant, efficient, and cost effective manner. Responsibilities include: Ability to learn basic processes and equipment and serves as a hands-on resource in Production. Cleaning, preparing, and sterilizing production equipment. Assembly, set-up, and disassembly of production equipment. Interfacing with process automation systems and electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP, LiveLink)

QA Specialist II will be required to: Support the quality team to achieve quality goals. Assist the quality team daily to accomplish efficient and effective review and approval of records as assigned including, but not limited to: calibration and maintenance work, procedures, validation protocols, validation reports, deviations and change controls. Communicate effectively with internal personnel, as well as external customers (if applicable).

The position will be responsible for downstream purification of recombinant viruses and will be a key member of the team developing expression and purification strategies for novel gene editing/gene therapy vectors. Responsibilities include: Contribute to a smart, integrated development approach for definition of scalable viral vector processes and suitable control strategies. Plan and perform experiments to develop purification process steps including chromatography (affinity, IEX, HIC, SEC, etc.) and filtration (depth filtration, UFDF, and sterile filtration). Perform experiments to develop robust downstream unit operations, using DoE, multivariate analysis, and other statistical tools.

The individual should possess strong core competencies in cell biology, molecular biology, assay development. Responsibilities include; Cell culture and cell line development using retro- and lenti-virus, CRISPR and downstream analysis of autophagy and signaling. Perform western blotting, FACS and imaging analysis to analyze autophagy and specific target activity in primary cells and cell lines. Aid in conducting genome-wide CRISPR screens for novel target ID. Use mouse tissue to both aid in the development of novel biomarkers and analyze key targets by protein and gene expression.

As an Associate, Biomanufacturing you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position. Work hours are Sunday to Wednesday (4/10). Responsibilities include: Operates cGMP Biomanufacturing equipment, including pH/conductivity, meters, mix tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH). Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) revisions, deviation investigations and change control/protocol execution, by established due dates.

Catalent has an opening for a Laboratory Associate Buffer Preparation, Manufacturing position. Responsibilities will include performing aseptic techniques within a clean room environment. As the Laboratory Associate Buffer Preparation, Manufacturing you will learn to execute and properly document biomanufacturing activities. Work schedule is Wednesday to Saturday, 7:00 a.m. to 5:00 p.m. CST. Operates cGMP Biomanufacturing equipment, including pH/conductivity, meters, mix tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH).

The Formulation Tech reports to the Production Manager. The position is entry level and responsible for learning the basic BFS technology, personal protective equipment, equipment use, and comprehension of formulation processes and methods such as: tank sterilization process, temperature recorder function, reading set-up drawings, tank compounding, and batch record documentation. This position is responsible for aseptic gowning certification as prerequisite to entering the Aseptic Suites. New hire is not intended to stay in this position long term. Once training and qualification is completed at this level, employee advances to Formulation Technician Level 1.

Responsibilities as a clinical data programer include: Provide data programming support to project teams for reporting and analysis of clinical data in early clinical studies. Develop, maintain and process SAS programs for standard studies that create case report forms (CRFs), edit checks (clinical), data listings, analysis data sets and electronic data transfers.

Responsibilities include: Verify Excel spreadsheets and calculations. Assist in paperwork routing, document assembly, and verification of information packet completeness. Verify raw data against information in Methods or Standard Operating Procedures: Ensure Compliance with general SOP requirements, Verify Solution composition or concentration, including calculations used to determine the concentrations are correct, Verify volumes used and any processing step documented are as explained in the sample processing procedures

We are seeking a Laboratory Assistant for our Contract Research Laboratory who will perform immunology testing of client specimens collected from both pre-clinical and clinical studies using the following test methods: ELISPOT, ELISA, flow cytometry, etc. You will help support our quality improvement projects in conjunction with QA, support our quality system by data quality control, communicate with fellow laboratory personnel, maintain laboratory equipment, write reports, etc. All work is performed according to general laboratory safety standards, internal standard operating procedures (SOPs), client protocols, and applicable international, federal and state regulations.

The position will be working in a chemical lab that manufactures liquid reagents in bulk quantities. Responsible for the overall operation of the bulk lab throughout the shift and ensure that all activities are compliant with the company’s Quality, Safety and departmental policies and standards. Essential functions include: Formulate bulk liquid reagents following standard operating procedures. Work safely with hazardous chemicals and follow all Safety policies to ensure zero incidents in the lab. Recommend or suggest improvement ideas in the lab that will positively affect production efficiency, Quality and Safety compliance

The Regulatory Submissions Specialist will serve as a team member for electronic submission publishing (primarily eCTD format) and SPL conversion projects. He/she will collaborate with the Synchrogenix team and interact with clients on routine project related correspondences. The Regulatory Submissions Specialist will be responsible for completing publishing tasks that are assigned in order to meet submission deadlines. Prepare, compile, scan, render, and maintain regulatory submissions to Regulatory Health Authorities and other government agencies worldwide. Publish documents by creating bookmarks and hyperlinks into submission files according to Synchrogenix and client policies.

Support in vivo oncology studies in mice as a member of the Veterinary Services Team. Conduct daily and weekly assessments and treatments of animals identified with abnormalities. Administer the health surveillance program as described, including animal and sample submission and tracking of results. Proficiently perform survival animal surgeries and provide perioperative care. Collect blood and tissue samples as dictated by study protocol or veterinary need

The position will work in the flow cytometry laboratory handling samples and preparing for flow cytometry evaluation. Perform standard cell biology techniques to process blood and tissue samples from multiple species. The laboratory process samples in a high-throughput, plate-based manner, requiring ability to use multichannel pipetting. Solid tissue and tumor samples will be dispersed into single cell suspensions. Samples may require cell counting and viability determination using cellometer, hemocytometer, flow cytometer, or other techniques. Sample handling may include cell washing, red blood cell depletion, stimulation, intracellular staining, fixation. Staining of samples with multicolor antibody cocktails. Some PBMC isolation and freezing down cells to create cell banks. Some tissue culture work may be required. He/she will follow SOPs and methods, and carefully record and document processes performed within the laboratory.

Support in vivo oncology studies in mice as a member of Cell Culture Team. Prepares passaged and primary cells for use by in vivo and in vitro technicians as directed. Produces, maintains and characterizes cultured cells, as directed. Performs related general duties such as inventorying supplies and reagents, general lab housekeeping, and maintaining safety records. Maintain accurate and detailed records using laboratory information management systems and Microsoft Office suite programs

Perform basic necropsy laboratory procedures. Participate in the documentation of all activities as required. Receive and ship samples. Assist with and perform basic necropsy procedures (basic dissection, tissue collection/preservation, fresh tissue trimming, sample collection, etc.). Learn/know correct anatomic terms. Receive samples, complete tracking documentation, and prepare pathology materials and data for shipment and archiving

We are seeking a Research Technician I for our Safety Assessment Group site located in Ashland, Ohio. Collect and record data with minimal supervision in the performance of studies. Responsible for handling and restraining animals, clinical observations, sample collection, monitoring food consumption, animal husbandry, and performing accurate data collection and reporting. Administer test substances by various basic methods.

In this position, the Laboratory Operations Technician I will be responsible for performing a variety of tasks involved in sample receiving and processing, and inventory management of critical components, laboratory supplies, specialty reagents, and client-supplied reagents and controls. Perform activities related to sample log in, processing, storage, shipping of materials client support, laboratory and facilities order placement, and order tracking, receiving, and processing.

This person will be responsible for participating in a wide variety of lab-based activities inlcuding: Routine wet chemistry. Operation of various analytical instruments (HPLC, LC/MS, and liquid handlers). Animal handling/husbandry. Animal procedures. Record keeping. etc.

The Clinical Research Associate (CRA) monitors activities at clinical trials sites to assure adherence to Good Clinical Practices (GCP), standard operating procedures, and study protocols. The CRA reviews regulatory documents as necessary, and prepares site visit reports. The person in this position is involved in the selection of potential clinical investigators and determines if facilities are adequate based on protocol requirements.

The Clinical Trial Assistant provides support to the clinical operations department to assist with execution and maintenance of clinical studies. Acts as a central support for the clinical team for designated project communications, correspondence, and associated documentation. Maintains, updates, and may establish various databases for clinical activity tracking. Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites.

The Psychometric Rater I is responsible for administering and interpreting quantitative tests for the measurement of psychological variables related to diseases and disorders, examples of which include, but are not limited to, Alzheimer’s disease, Mild Cognitive Impairment, Multiple Sclerosis, Depression, Anxiety, and Parkinson’s Disease. This position is responsible for managing the psychometric ratings aspect of clinical trial performance at the site level in order to ensure that the data collection is in congruence with the philosophy and mission of the company, as well as with the specific scale administration guidelines. The Psychometric Rater I follows study-specific protocol guidelines and communicates and interacts with Investigators, clinic staff, sponsoring agencies, and others to effectively perform required testing and related research activities.

Responsibilities include: Communicates with Clinical Project Managers, Clinical Operations Associates and/or Specialists regarding image quality, deliverables, and data discrepancies. Communicates with Image Analysis Lead, Clinical Operations Manager, and/or Scientific Director regarding troubleshooting of reading systems, image quality concerns, and deliverables. Maintains study-specific reading tracking tools. Performs quality control of site qualification- scans using phantom or patient, and on-going patient data within study-specific turnaround times to Clinical Project Manager, Clinical Operations Associate, and/or Specialist responsible for the study. Completes validation of relevant central analysis types by meeting pre-defined validation requirements.

Medical Assistant works in a clinic setting and handles basic clinical task and performs administrative/office duties. Interacts with patients and assist physician to ensure operations run smoothly and efficiently. Responsibilities include: Answer incoming calls, take messages and/or respond to all calls within 24 hours. Schedule patient appointments. Perform clinical task including but not limited to vital signs and height/weight; document medical history in patient charts. Call and/or fax RX request to pharmacy and obtain preauthorization, if necessary once approved by physician

The Lab Technician is responsible for the overall specimen processing and handling according to specific protocol requirements and Bioclinica Research SOP. Responsibilities include: Specimen handling, Perform lab tests, Prepare and process blood, urine and other samples for in house test, reference lab or central lab according to specific study protocol and/or SOP, Perform blood draws, specimen collection, take vital signs, perform EKG testing and able to record accordingly

This function includes: Analytical Support – Support functions include, but are not limited to: review and approval of in-process testing, release testing of products, stability testing, other data summaries, method validation data, laboratory equipment validation protocols, product certificates of analysis, generation of environmental chamber monitoring reports. Other duties as deemed appropriate by Head of Quality. Manufacturing Support, Document Control, Internal Audits and Client / Regulatory Audits, Equipment and Facilities Calibration, Maintenance, Validation, Preventive Maintenance

The Product Development Research Associate will be responsible for developing cutting edge recombinant protein research products for the Molecular Cellular Immunology group. This position will be involved with developing a new line of recombinant protein products by supporting other team members. The typical duties include preparing buffer solutions and cell culture media, performing bacterial and mammalian cells cultures, purifying recombinant proteins with affinity tag, and performing PCR and DNA purification according to standard operating procedures.

BioLegend is currently seeking a talented, detail-oriented Quality Control Associate to join our growing Custom Solutions Team. This position will be responsible for assisting with flow cytometry based QC testing, analysis, documentation, and will help maintain relevant databases.

BioLegend has an immediate opening for a Quality Control Associate that will be responsible for testing products such as antibodies and proteins in the following application(s): flow cytometry, immunohistochemistry, western blotting, ELISA, multiplex immunoassays and/or functional bioassays. This position will also perform all aspects of the assays following SOPs and ISO requirements. Additional responsibilities include culturing mammalian cell lines, isolating primary cells, and maintaining laboratory equipment and supplies.

This laboratory based position requires technical expertise in protein characterization and purification systems in support of ongoing manufacturing operations. He or she participates in monitoring and troubleshooting existing processes to build a detailed process understanding and developing process improvements consistent with cGMP. This position involves collaboration with process development, manufacturing, quality control, and quality assurance groups. Travel is limited to attending relevant professional conferences and workshops.

Responsible for efficient and effective laboratory operations, the Research Associate I has a significant impact on the company's ability to reach project goals in a timely manner with respect to delivery of data to support pre-clinical and clinical studies critical to advancing programs through the development process. The Research Associate I will perform bioanalysis, using validated PK or immunoassay methods, on non-clinical and clinical samples in a GLP compliant environment. Responsibilities can include sample preparation, sample analysis, GLP documentation, report generation, assay validation and troubleshooting, and interaction with BioMarin’s GLP quality assurance unit.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. Duties as an Analyst include: Perform, under direct supervision, chemical analyses of incoming raw materials under cGMP to meet specified timelines. Evaluate results and trend data. Maintain raw materials log and control of laboratory inventories. Maintain the laboratory in an inspection ready state.

This position requires an individual with strong problem solving skills, good laboratory technique, and the ability to execute complex experiments. The successful candidate will have a desire to learn and the strong attention to detail. This position will entail running of automated oligonucleotide synthesizers as well as synthetic chemistry and/or molecular biology laboratory work to support new product development.

Responsible for design/development, modification, and evaluation of primarily mechanical systems, equipment and packages. May contribute to total systems engineering, including other eng. disciplines. Conducts feasibility studies and tests new and modified designs. Is involved in all phases of development from initial concept to manufacturing. Directs support personnel in the preparation of detailed design, design testing and prototype fabrication. Provides design information to drafting for packaging documentation. Depending on level may function as a project engineer/leader with the resident responsibilities of proposals/project plan, schedules, work assignments, prime contact, technical presentations, cross functional issue resolution, etc.

The Manufacturing Chemist I is responsible for processing and formulation of controls, calibrators, working solutions, and intermediates according to approved standard operating procedures. Responsible for manufacturing quality products on schedule. General knowledge and basic application of concepts, theories, terminology and practices that apply to manufacturing in a laboratory environment.

Bio-Technical Resources is seeking an Assistant Research Scientist to work with supervision as an analytical research assistant supporting teamsdeveloping fermentation and biotransformation processes for the production of antibiotics, enzymes, proteins, chemicals, and metabolites. The position involvesimplementation of HPLC, chromatography, enzyme assays, and gel-basedanalytical methods.Common tasks include analytical separations and quantitative analyses

(Associate Level) Executes routine unit operations in Upstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures. Executes, with oversight of qualified staff, complex unit operations including but not limited to batching and inoculation of bioreactors, operation of bioreactors, process monitoring, and harvest operations. Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.

Non-Lab position. The Sample Management Technician is responsible for ensuring that all samples are entered into the Laboratory Information Management System (LIMS) and made available to the lab staff in a timely manner. This position reports to the manager of Stability and Sample Management. The Technician’s responsibilities include, but are not limited to, the following: Performs any combination of sample management tasks, including labeling, preparing for shipping, transporting to labs, inventorying and disposing. Reviews and verifies sample paperwork against samples to ensure accuracy and communicate discrepancies. Distributes sample information and paperwork.

The Process Engineer I is responsible for developing and maintaining capable processes and ensuring efficient and effective sterilization operation. This person will apply problem solving skills to enable sterilization innovation while using technical and collaboration skills alongside his/her passion for innovation and continuous improvement to drive growth through efficient and effective process improvements. Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on multiple and moderately complex processes. Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.

The Scientist will provide biologics process development support to ensure that the Brammer Bio Downstream Process Development (DSPD) unit operates to provide clients with new purification methods and investigational materials for pre-clinical and clinical use. The incumbent will assist in the design and execution of experiments under the supervision of the technical project lead. This will involve researching and sourcing reagents, equipment, and materials; preparing columns; purifying viral vectors utilizing working knowledge in filtration technologies, column chromatography (SEC, affinity, HIC, AEX), ultracentrifugation and scale up principles. This position will also be expected to technically review data, prepare experiments/data for presentation, participate in laboratory investigations, interpret this data and work with the project lead to trouble-shoot technical problems. The incumbent will participate in the optimization of purification methods and the writing and troubleshooting of protocols. The incumbent is expected to prepare and modify documents (SOPs, Batch Records, Raw Material Specifications, etc), maintain a GLP culture, and assist in maintaining the process development laboratory.

The primary responsibility is to support the technology transfer teams for the late stage, PPQ and commercial manufacturing of viral vectors. This position requires close interaction with the MS&T colleagues, Manufacturing, Process Development, and other departments. This role will focus on aspects of ensuring a robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial gene transfer vector products. Supports cross functional technology transfer teams for cGMP DS manufacturing of viral vectors. Collaborate with another site or clients to ensure success of scale up/ process transfer. Includes authoring of upstream or downstream plan documentation and associated detail process descriptions (DPDs).

Responsibilities include: Conduct experiments to support cryogenics manufacturing processes of commercial and late-stage biologics drug substance. The candidate will support bulk container selection and freezing, storage, and thawing operations for biologics drug substance. Support validation of the freezing and thawing processes of commercial and late-stage biologics drug substance across BMS global network and contract storage/manufacturing sites. Follow appropriate GLP/GMP procedures. Study design, execution and analysis of results, data verification, preparation of study protocols and final reports, and the presentation of findings at internal and external forums

This associated scientist position within the analytical methods team has the opportunity to drive the development and validation of robust separation methods (e.g., CE-SDS, iCIEF, SEC, RP, IEX, HIC) for biotherapeutic drug candidates in the portfolio spanning early and late stage clinical programs. Bristol-Myers Squibb's biologics pipeline includes approved biologics products such as OPDIVO®, YERVOY®, EMPLICITI®, ORENCIA®, and NULOJIX®, and a number of exciting clinical stage compounds as well as antibody combination products. Development of methods utilizes state-of-the-art analytics as well as modern concepts of quality attribute monitoring of biotechnology products. Science-based research and molecular-level understanding of protein properties are critical for successfully performing method development. Innovation is central to establishing robust analytical control and define our overall biologics development strategy. The successful candidate will also support regulatory filing activities including IND and BLA, as necessary. This position reports to manager in Methods and Analytical Development function of the Biologics Development organization.

Support the operation of GMP / Non GMP manufacturing systems (Systems include Process Automation Systems, Manufacturing Execution Systems, Process Development, Technology Transfer, Laboratory, Manufacturing Operations) in the associated facilities. Provide Troubleshooting support and guidance of systems in support of manufacturing, process development, and/or Lab operations within a collaborative team. Collaborate in investigations of proprietary automation software/hardware, manufacturing operations, process development, along with vendors when necessary. Documentation of data and results, data verification, interpretation of small scale and at scale data supporting the manufacturing processes and preparation of final reports to summarize the findings.

As a Manufacturing Quality Engineer, you will be the primary quality interface for new and existing products. You will design, develop, and execute quality assurance and control systems. Use your expertise and judgment in implementing a wide variety of quality concepts, practices, and procedures. You will contribute to product and manufacturing process design, as well as the methods for verification and validation of product to ensure adherence to company and customer requirements. You will work toward the prevention and/or resolution of product and manufacturing process non-conformance. You are well versed in working with Contract Manufacturers (CM) and Component Suppliers. You will lead teams to ensure products are designed and built to Bruker’s high standards of quality and performance. You will evaluate the product designs and create the processes, tools and procedures behind Bruker’s world leading Handheld X-Ray Fluorescence (XRF) products. You will collaborate with Commodity Managers and Design Engineers to determine Bruker’s manufacturing and product specifications

Responsible for coordinating and providing engineering support throughout the manufacturing facility in areas such as process improvements, technological advancements, cost improvements, facility maintenance, safety, and environmental regulation. Coordinate and participate in plant CIP and process improvement programs as required.Support, or lead as required, activities such as failure investigation, design of experiments, process capability studies, qualifications, and validations of processes and equipment. Coordinate tactical plans geared towards timely completion of line extensions and major equipment installations, modifications, or enhancements.

This list is not comprehensive but meant to represent the most common or important duties of the position. Develop, document and implement standard molding processes and methodologies. Use scientific molding method to validate new molding processes and re-validate existing/legacy molds. Research, design and develop manufacturing processes and new technologies. Participate in Tool Design Reviews and recommend improvements to optimize molding, setup, and overall manufacturing. Work with design, manufacturing, production, engineers and tooling during the entire development cycle. Emphasis on new mold sampling prior to transfer to production. Research, develop and implement manufacturing process controls, machinery modifications and improvements.

This is a hands-on lab-based role in Induced Pluripotent Stem Cells (iPSCs) group with a focus on iPSC genome engineering and differentiation using ASC’s gene editing technologies. Responsibilities include: Work closely with a multi-function team to deliver engineered iPSCs cell lines and a variety of other cell types. Work on gene editing projects in iPSCs/stem cells, preparing reagents, performing cell culture and cell-based assays. Work on iPSCs generation, differentiation and characterization. Apply scientific knowledge, critical thinking, and problem-solving abilities to troubleshoot and refine methods and assays. Interpret genotyping data from Sanger sequencing and Nextgen sequencing

The primary mission of our Technicians is to operate injection molding equipment to successfully meet production demands and quality standards. Duties include but are not limited to: Utilize your mechanical skills to install, remove and adjust Injection Molding machinery and equipment. Troubleshoot Injection Molding machines, follow process to resolve failures, other problems. Coordinates and sets up machines, robots and other equipment performing necessary tests to ensure company compliance. Trains employees in the correct procedures for operation as needed. Assist in preventative maintenance and repair of molding machines, molds and peripherals (robots).

On the Software Engineering Infrastructure team, you will apply your expertise in Python and large scale distributed systems, building data processing pipelines and interactive tools.

The job requires the application of creative problem-solving approaches to the execution of new biochemical and cell-based assays. Responsibilities include, but are not limited to: Performing routine assays to support chemistry efforts. Execution of new biochemical and cell-based assays. Practical laboratory work, managing day to day tasks and ensuring timely delivery of high-quality results. Utilizing liquid handling systems and laboratory robotics to implement in vitro assays. Contribute during lab meetings and assist in the analysis and reporting of experimental data to project teams.

The Biology group is seeking a self-motivated, collaborative and highly skilled individual who wishes to play a key role in advancing novel immunotherapy drug candidates from the discovery phase into the clinic. The data generated by the in-vivo team is central to advancing our understanding of the mechanism of action of our drug candidates and potential combination partners. Specific responsibilities will include collaborating with the project team to conduct tumor efficacy studies in both syngeneic and xenograft models. In addition to taking point on in-vivo efficacy studies the successful candidate will be involved in the ex-vivo analysis of tumor samples. Additional duties could also include in-vitro responsibilities such as the maintenance and preparation of cell lines for tumor studies.

This role will be responsible for QA oversight of all GxP Computer Systems. The incumbent, working with the functional teams must ensure that all GxP regulated systems are purchased, audited, installed and maintained based on industry best practices (e.g. GAMP5) and regulatory requirements (e.g. 21CFR Part 11 and relevant FDA Guidance). The position plans and organizes all QA activities for computer system validation projects. Duties include, but are not limited to, oversight and approval of validation - related documents, leading risk assessments and working with project team to determine which elements should be validated, conducting and/or coordinating impact assessments of proposed changes to computerized systems and leading inspection (external/internal) readiness activities related to computer system validation. The candidate will ensure that all GxP computer systems are maintained in a validated state in addition to designing work processes for users and administrators of the aforementioned systems.

We are seeking a highly motivated Cell Culture Biologist with excellent organizational, problem solving, and communication skills to join our Structural Biology group located in Boulder, Colorado. This scientist will be responsible for maintaining and scaling up (≥5L) insect cell and E. coli cultures in suspension for recombinant protein expressions. The individual will also be involved in molecular cloning and construct design. A track record of excellent aseptic techniques and experience in molecular biology and protein expression are essential for this role.

This is an ideal position for an individual with an organic or biological chemistry background who has an interest in projects related to novel technology in synthesis and purification of oligonucleotides and bioconjugates. The successful candidate will be expected to: Perform solid-phase synthesis and purification of oligonucleotide drug candidates. Analyze small-molecule and macromolecular targets using standard methods, such as HPLC, UV-Vis spectrophotometry, mass spectrometry, NMR, etc. Track progress against project timelines, generate regular status updates, and communicate progress and issues to management, including presentation of findings at team meetings

We are actively seeking an Automation Engineer I to provide automation and equipment development and support expertise to the Final Device Assembly and Packaging engineering group. This engineer will be a resource for all activities required to build, program, install, debug, and implement automated equipment. The successful candidate will have strong communication and analytical skills, knowledge of manufacturing process and a Bachelor’s degree in Engineering or Engineering Technology.

In this position, the successful candidate will apply their skills and expertise in protein biochemistry to identify targets bound by patient derived antibodies using protein biochemistry and molecular biology techniques. These include protein and carbohydrate arrays, immunoprecipitation, and other protein biochemistry techniques. Responsibilities include: Perform immunoprecipitation and array screening of antibodies selected for testing in in-vivo tumor models. Generate lysates and subcellular fractions from tissue culture cells (including radiolabeled cells) and mouse tumors. Perform pilot immunoprecipitation screens on lysates from tumors and radiolabeled cells.

The Associate Process Engineer is responsible for on-going production, validations, and continuous improvement of new and existing manufacturing processes. He/she contributes in a creative and collaborative ways to achieve the company’s goals of producing market leading products through positive patient outcomes. Responsibilities include: Team member of projects involving design, manufacturing, and quality resources, both internal and external. Knowledge of general manufacturing technologies (plastic injection molding, stamping, milling, turning, assembly methods, various fastening techniques) including low to medium volume manufacturing processes. Able to define, communicate, and develop fixture concepts using internal and external resources. Able to incorporate the capabilities of typical production association into these concepts

This entry-level position is within our production group. The work includes following standard operating procedures for using automated liquid handling stations, interfacing with our in-house database, providing support in various lab functions including PCR, making agarose gels, growing culture from stock, organizing/purging storage plates, and interacting with our bioinformatics department.

We are currently hiring a field-based Specialty Pharmaceutical Sales Representative who will be able to drive branded prescription sales in their assigned territory. The Specialty Pharmaceutical Sales Representative will promote our growing portfolio of innovative, branded prescription pharmaceutical and dietary supplement products in Women’s Health, Hematology, Dermatology, and related specialties. The primary call point will be OB-GYN’s offices in their territory, calling on assigned healthcare providers, informing those providers on the features and benefits of our products to effectively grow our market share.

The Clinical Trials Assistant is responsible for supporting the organization to successfully develop and implement clinical trials across its product portfolio and development pipeline. The Clinical Trial Assistant provides a key support function to the clinical operations team. Under general guidance from Clinical Operations, you will support the Clinical team responsible for management of multiple clinical trials (all phases), and assure compliance with SOPs, FDA regulations, GCP and ICH guidelines.

Duties and responsibilities include: Conduct critical chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Baxter manufacturing facilities. Work under minimum supervision. Use sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced assays requiring precise analytical skills and understanding of biology and chemistry principles. Complete all testing, including special project / protocol testing in a timely and appropriate manner. Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.

This position is a key role in Maintenance in our Manufacturing Operations. Primary focus will be on implementing continuous improvement, new business, and capacity expansion projects. Additional focus will also be on manufacturing equipment reliability and process support working within the Operations Group and Engineering. Cross-functional project management will be involved in this role as well. Duties include: Design/modify precision assembly and/or manufacturing equipment. Manage multiple projects with minimal supervision. Prepare estimates for various tasks and projects. Manage capital projects both directly and through coordinating engineers.

Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of Baxter’s products. Responsibilities include: Track of status and progress of regulatory documentation. Review, edit and proofread regulatory documentation. Assist in preparation and review of labeling, SOP’s, and other departmental documents. Compile under supervision regulatory documents for submission

The primary responsibilities of this role, Data Engineering Graduate Scholar, are to: Design and develop pipelines to connect external data sources to a data lake in a collaborative effort with Bayer R&D IT and Bayer Biologics; Design and develop workflows to link datasets in the data lake based on shared ontologies; Design and develop REST APIs and web-based UIs to provide access to linked datasets in the data store; Gain expertise in frameworks for schema discovery from schema free sources and use expertise gained to extract knowledge from existing schema-free sources; Design and develop workflows to link datasets in the data lake based on shared ontologies;

This position is responsible for coordinating and providing engineering support throughout the manufacturing facility in areas such as process improvements, technological advancements, cost improvements, facility maintenance, safety, and environmental regulation. Essential job functions include: Coordinate and participate in plant CIP and process improvement programs as required. Support, or lead as required, activities such as failure investigation, design of experiments, process capability studies, qualifications, and validations of processes and equipment. Coordinate tactical plans geared towards timely completion of line extensions and major equipment installations, modifications, or enhancements.

Medical Assistant works in a clinic setting and handles basic clinical task and performs administrative/office duties. Interacts with patients and assist physician to ensure operations run smoothly and efficiently. Answer incoming calls, take messages and/or respond to all calls within 24 hours. Schedule patient appointments. Perform clinical task including but not limited to vital signs and height/weight; document medical history in patient charts. Prepare patient for examination. Ensure examination room is clean, well-equipped, and ready at all times

You will beresponsible for developing applications and products for Opal Multiplex Fluorescent IHC Reagents which are designed specifically for Akoya’s cutting-edge Mantra and Vectra Polaris multispectral imaging systems.The desired skillset for laboratory work includes the ability to perform immunohistochemistry (IHC) procedures to support theproductdevelopment. Your work will involve manual laboratory work and the use of automated stainersystems for monoplex and multiplex fluorescence tissue staining.

To conduct formulation preparation or analytical test in direct support of the drug development team, including writing documents and reports. Responsible for the maintenance of lab instrumentation and general lab duties. Prepare drug formulations according to established procedures. Analyze test data, recognize results that are abnormal or deviate from those expected. Recognize equipment malfunction and factors affecting measurements and testing. Evaluate and solve problems related to sample preparation, variation and processing

Under close supervision, this position is responsible for a variety of manufacturing support functions involving the operation of lab equipment and conduct of procedures/tasks according to established GMP, under the direction of senior staff. Responsibilities include: Carry out production tasks in support of manufacturing goals and objectives. Operate laboratory equipment safely, as trained and directed, in accordance with established practices. Maintain records and notebooks as directed in a neat, thorough and accurate manner. Perform required data entry on company planning and materials management system. Report results to supervisor. Perform complex formulations, component and material evaluations, equipment calibrations and maintenance

The position of Production Specialist I is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will perform work required for the assembly of components, devices, and/or the final product depending on the trade assigned. Duties include: Performs work required for the assembly of components, devices and/or the final product with supervision. Ensures quality of product using standard operating procedures, templates, training and supervision, and good judgment.

Responsibilities include: Conduct research on various drug/device interactions as part of the drug delivery and device development process. Analyze and interpret data from various product development experiments. Exercise technical discretion in the design, execution and interpretation of experiments that contribute to project objectives. Contribute to stability studies. Ensure reproducible and reliable results for protocols related to development of drug delivery systems.

The role will use in vivostudies to primarily assess CNS mechanisms through rodent behavioral, histological and biochemical techniques. The role is critical in assisting the scientific team in advancing our therapeutic understandings. This person will be involved in establishing, validating, and implementing methodologies in Alkahest’s laboratories and is thus pivotal to the company’s mission. The studies performed will involve cutting edge science and require innovative concepts and strategies. The role requires dedication to drive science, flexibility, excellent communication and organization, and will interact with a team of scientists and research associates to drive multiple projects in parallel.

Under the supervision of supplier quality management, the Supplier Quality Engineer I will support all aspects of the Supplier Quality processes which include but not limited to the items listed below. Complies with FDA, ISO, AATB, and all other applicable international and state regulatory requirements, best industry practices and internal processes. Identify and bring issues to management when a compliance gap is identified.

The inventory expeditor will work with other members of the inventory team to increase company profitability and customer satisfaction by delivering complete, accurate and on-time deliveries to the company’s customers. Responsibilities include: Deliver orders/inventory via the most effective route to ensure devices/products are delivered according to established time frames. Maintain communication with the Inventory Manager during deliveries to ensure any updated instructions are received. Operates a motor vehicle according to applicable state laws as needed.

Research Associate I is responsible for assisting senior R&D staffs to design, develop, and validate clinical diagnostic assays spanning a wide range of Next-Generation sequencing and microarray technologies. Duties include: Aid in the design and development of clinical diagnostic assays for use in a CLIA/CAP regulated setting. Participate in drafting Standard Operating Procedures for new assays. Perform research experiments, such as primer design and preparation, PCR, electrophoresis, gel imaging and analysis, Sanger Sequencing, Next-Gen sequencing library preparation, aCGH microarray labeling, and sequencing analysis.